[{"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Sr. Product Surveillance Specialist\nLocation: United States-California-Aliso Viejo Site\n\nReceiving, evaluating, and documenting information on all domestic and international complaint files\nMust be able to make adverse event reporting determinations to meet FDA, ISO and international regulatory requirements\nMust be able to file regulatory reports to appropriate regulatory agencies\nAbility to interact with Quality Assurance, Engineering, and others as required to address DHR review, root cause analysis and process review to prevent recurrence\nDuties include ability to perform data entry, create file folders, labels, letters, filing, fax, scan, and associated duties as required\nContacting complainant via phone or letter to clarify or obtain additional technical information to resolve complaint\nAbility to interpret, follow and make required revisions to standard operation procedures required\nCompile, review and close complaint files\nAssist with projects as required\n\n\nBausch  Lomb is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. The company is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world \u2013 from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better.\n\nBausch  Lomb is an equal opportunity employer.\nPosition requires 5-8 years of related work experience.\n\nBachelor's degree is required (preferably in a health related field).\n\nKnowledge of ophthalmic medical terms, Medical Device Reporting\nregulations, Vigilance reporting regulations, and GMPs for medical devices\npreferred.\n\nPosition requires strong written, verbal and listening communication skills\nin order to interact with customers and other professionals. Candidate must be\nable to generate and organize clear, concise responses at different levels of\nmanagement is required.\n\nCandidate must be proficient in the use of personal computer, including\ndatabase management, trending and word processing.\nJob: Quality", "date_new": "2012-05-15 19:56:44", "url": "http://bausch.jobs/xml/28707347/job", "country": "United States", "company": "Bausch + Lomb", "title": "Sr. Product Surveillance Specialist", "reqid": "00007711", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28707347}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Global Regulatory Affairs, Manager\nLocation: United States-California-Aliso Viejo Site\nThe Surgical Regulatory Affairs Manager handles all regulatory development aspects for surgical devices as assigned. These include IOLs, Inserters and Solutions. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities.\n\n\nESSENTIAL DUTIES AND RESPONSIBILITIES:\nResponsible for developing a global product regulatory strategy for surgical devices\nResponsible for obtaining and maintaining all US and EU approvals\nResponsible for developing and maintaining EU Tech Files and ROW Master Files\nLiaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development\nDevelop a product regulatory timeline aligned to Bausch & Lomb\u2019s product development, with key regulatory milestone, and activities for agency filing\nCoordinate with the team on the development of product labels\nEnsure labeling content and product documentation is developed in accordance with regulatory requirements\nParticipate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions\nCoordinate with RA Global Expansion team to ensure timely and accurate submissions to Regulatory Authorities\nAct as a regulatory contact for assigned country Regulatory Authorities for surgical devices\nManage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections\nProvide regulatory guidance/input to surgical device change control and internal product review boards \n\n\nTECHNICAL COMPETENCIES:\nKnowledge of surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations\nKnowledge of domestic and international laws, regulations, and guidance that affect assigned devices\nKnowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses\nAbility to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices\nAbility to influence and partner with cross-functional teams in a global surgical organization\nAbility to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval\nAbility to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data\nAbility to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.\n\nPROFESSIONAL COMPETENCIES:\nDemonstrated ability in analytical reasoning and critical thinking skills\nStrong capability to contribute and lead a team environment\nStrong business acumen and ability to see the business drivers outside of Regulatory Affairs\nExcellent communication skills; both oral and written\nStrong interpersonal skills with the ability to influence others in a positive and effective manner\nDemonstrated ability to contribute to a continuous learning and process improvement environment\nCapacity to react quickly and decisively in unexpected situations\nDetail-oriented with the ability to proofread and check documents for accuracy and inconsistencies\nFocused ability to influence operational excellence and performance metrics\nRisk adverse where needed with the ability to identify potential solutions to complex problems\n\n\nBausch\nLomb is one of the best-known and most respected healthcare brands in the\nworld, offering the widest and finest range of eye health products including\ncontact lenses and lens care products, pharmaceuticals, intraocular lenses and\nother eye surgery products. The company is solely dedicated to protecting\nand enhancing the gift of sight for millions of people around the world \u2013 from\nthe moment of birth through every phase of life. Our mission is simple\nyet powerful: Helping you see better to live better.\nBausch\nLomb is an equal opportunity employer.\n\n8 years relevant medical device industry and regulatory experience\nOphthalmic Surgical device regulatory experience highly preferred\nBachelors degree in science or health related field preferred\nAdvanced degree preferred (PhD, MD, MS, PharmD, or equivalent)\n\nJob: Regulatory Affairs", "date_new": "2012-05-10 20:29:31", "url": "http://bausch.jobs/xml/28612454/job", "country": "United States", "company": "Bausch + Lomb", "title": "Global Regulatory Affairs, Manager", "reqid": "00007684", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28612454}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Research & Development Intern\nLocation: United States-California-Aliso Viejo Site\n\nThis technician will participate fully in surgical Intraocular Lens (IOL's) / Injector processing / testing activities on key R & D projects in development labs.\n\nSpecific Job Duties\nConduct IOL / Injector processing activities; lathing, milling, wet/dry processing, packaging, testing etc. as it pertains to IOL's / Injector's.\nPerform cosmetic, dimensional, and other forms of inspections / testing in a research environment.\nSet-up and operate manual, semi-automatic and fully automated research equipment, fixtures gages, etc.\nAssist engineers in the processing studies and validation of equipment/processes.\nInterface with other functional groups and peers\nRecord and analyze test data, maintain logbooks and generate reports.\nEnsure adherence to protocol procedures, SOP\u2019s, GMP\u2019s and specifications.\nBe a flexible participant in cross functional teams and be able to multi task.\n\nEducation: High School Diploma; some college level or job related training required\nExperience: 1-2 years, Medical device and/or clean room environment a plus.\nSpecial Skills: Experience with research lab environment or regulated manufacturing. Knowledge of computers/shop floor control systems, ability to handle multiple tasks, excellent communication and documentation skills.\nSpecialized Training: ISO, GMP, research / production experience with Surgical IOLs' / Injectors, dry/wet lens processing , cosmetic inspection, dimensional audits; sag/diameter, power, IOl delivery will be required.\n\n\nJob: Marketing", "date_new": "2012-05-07 18:35:53", "url": "http://bausch.jobs/xml/28481704/job", "country": "United States", "company": "Bausch + Lomb", "title": "Research & Development Intern", "reqid": "00007698", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28481704}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Regulatory Affairs Intern\nLocation: United States-California-Aliso Viejo Site\n\nBausch & Lomb Surgical develops, manufactures and distributes ophthalmic surgical devices for the U.S. and international markets.  This position requires the incumbent to work under the direct supervision of senior regulatory professionals in the collection and collation of materials required for various country submissions. Additional duties include:\n\n\u2022 Support preparation of data packages\n\u2022 Coordinate global regulatory assessments\n\u2022 Organize archived documentation\n\u2022 Track and communicate international approvals data\n\u2022 Produce draft documents for registration renewals tofacilitate the maintenance of product approvals.\n\n\n\u2022 Excellent writing and verbal communication skills\n\u2022 Some working knowledge of global device regulations\n\u2022 Strong problem-solving and analytical ability\n\u2022 Required computer skills include Microsoft Word and Microsoft Excel.\n\u2022 Comfortable working in a variety of corporate business management computer systems.\n\u2022 Background in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law.\n\nJob: Regulatory Affairs", "date_new": "2012-05-07 18:35:37", "url": "http://bausch.jobs/xml/28481698/job", "country": "United States", "company": "Bausch + Lomb", "title": "Regulatory Affairs Intern", "reqid": "00007699", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28481698}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: BUSINESS DEVELOPMENT INTERN\nLocation: United States-California-Aliso Viejo Site\n\nBausch  Lomb is one of the best-known and most respected healthcare companies in the world. Its core businesses include contact lenses and lens care products, ophthalmic surgical devices and instruments, and ophthalmic pharmaceuticals. Founded in 1853, the company is headquartered in Rochester, N.Y., and employs more than 10,000 people worldwide. Its products are available in more than 100 countries.\n\nABOUT THE BUSINESS DEVELOPMENT TEAM:\n\nThe Business Development team at Bausch  Lomb, Global Surgical is responsible for evaluating new business opportunities, reviewing and executing acquisition opportunities, and making strategic investment decisions. The group identifies products and companies that can lead to meaningful advancements in eyecare solutions, support Bausch  Lomb\u2019s patient-centered business strategy, and maximize the company\u2019s position within the ophthalmic medical device industry.\n\nRESPONSIBILITIES:\n\nInterns will spend their time immersed in Bausch  Lomb\u2019s entrepreneurial environment and business development process, working with the business development team, surgical leadership team, and various functional experts to drive existing business development ventures and assess future business development opportunities.\n\nPotential projects may include:\n\u2022 Performing market and competitor research and analysis\n\u2022 Supporting business case development for key acquisitions\n\u2022 Organizing diligence materials for acquisition targets\n\n\n\u2022 Ideal candidate will be pursuing an MBA from a top university with 2-4 years of work experience post business school\n\u2022 Experience in consulting, medical devices, investment banking, or marketing preferred\n\u2022 Demonstrated analytical ability\n\u2022 Strong communication skills\n\u2022 Deliverable-focused, strong work ethic\n\u2022 Project orientation and ability to handle simultaneous functions\n\u2022 Proven success in a demanding, entrepreneurial environment\n\u2022 Interest in medical devices/ophthalmology\n\u2022 Excellent attention to detail\n\n\nJob: Sales", "date_new": "2012-05-07 18:35:17", "url": "http://bausch.jobs/xml/28481695/job", "country": "United States", "company": "Bausch + Lomb", "title": "BUSINESS DEVELOPMENT INTERN", "reqid": "00007700", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28481695}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Marketing Intern \u2013 Crystalens\nLocation: United States-California-Aliso Viejo Site\n\nPOSITION SUMMARY:\nThe Marketing Intern \u2013 Crystalens will be responsible for working with the Marketing team for 8-10 weeks during the summer of 2012 in a temporary role. This internship will focus on several meaningful projects aimed at advancing Bausch  Lomb\u2019s business objectives as well as providing the intern valuable, hands-on business experience.\n\nThe ideal candidate will demonstrate a history of a high degree of accuracy and attention to detail and will be able to manage multiple projects by demonstrating a strong understanding of prioritization.\n\nPROJECTS:\nAssemble, organize , and participate in the creation of materials supporting Crystalens, including:\nSurgeon slide presentations\nSurgical videos\nPromotional sales tools\nTraining materials\n\nProject will include identification and modification of an online resource with access controls for various team members. Will require communication with the US sales team and global team members to gather information on currently used materials. Will also require interface with Medical/Legal Review process to ensure appropriate clearance for all materials by market.\n\nUpdate and consolidate Crystalens websites:\nWork with web team to devise a cohesive web strategy for both consumer and professional audiences to drive utilization and awareness of Crystalens.\nCurrently have several websites for both Professional, Consumer and Disease Education and want to maximize our web presence\nWork in concert with B L digital initiatives team to ensure alignment with corporate processes and procedures, working within the framework of Bausch.com and corporate branding guidelines.\n\nAssemble and asses new data from for useful clinical information to support Crystalens\nConduct an analysis of current data available on Surgivision DataLink to be used in the promotion and education\nPartner with Medical Affairs and Creative Agency to package Clinical Information for Sales Force Promotion\n\nSuccess Criteria\nOrigination of Marketing materials on the Sales Order website and Global sharing website\nDigital strategy for Crystalens websites (or webpages on Bauch.com)\nUnderstanding of data to be used in promotion\n\n\n\n\u2022 Demonstration of good written and verbal communication skills\n\u2022 Prefer background and/or interest in web development and digital media\n\u2022 Ability to work in a dynamic environment\n\u2022 Marketing focus\n\u2022 High School diploma required. Current student in 4 year degree program.\n\u2022 Proficiency with Microsoft Office tools\n\nJob: Marketing", "date_new": "2012-05-05 19:45:37", "url": "http://bausch.jobs/xml/28466752/job", "country": "United States", "company": "Bausch + Lomb", "title": "Marketing Intern \u2013 Crystalens", "reqid": "00007694", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28466752}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Marketing Intern \u2013 Equipment Marketing\nLocation: United States-California-Aliso Viejo Site\n\nPOSITION SUMMARY:\nThe Marketing Intern \u2013 Equipment Marketing will be responsible for working with the Marketing team for 8-10 weeks during the summer of 2012 in a temporary role. This internship will focus on several meaningful projects aimed at advancing Bausch  Lomb\u2019s business objectives as well as providing the intern valuable, hands-on business experience.\n\nThe ideal candidate will demonstrate a history of a high degree of accuracy and attention to detail and will be able to manage multiple projects by demonstrating a strong understanding of prioritization.\n\nProjects:\nAssemble, organize , and create in a competitive landscape overview:\nMarket analysis of cataract and retina: market size, key drivers, and differentiation\nTraining materials\nProject will include identification and modification of an online resource with access controls for various team members. Will require communication with the US sales team and global team members to gather information on currently used materials. Will also require interface with Medical/Legal Review process to ensure appropriate clearance for all materials by market.\n\nUpdate and consolidate Stellaris and Stellaris PC websites:\nWork with brand and web team to devise a cohesive web strategy for professional audiences to drive utilization and awareness of Stellaris and Stellaris PC.\nCurrently the websites are not tied-in and/or not updated with new messaging\nWork in concert with B L digital initiatives team to ensure alignment with corporate processes and procedures, working within the framework of Bausch.com and corporate branding guidelines.\n\nAssemble and assess sales data from for 2012 marketing strategy to support top-line growth\nConduct an analysis of current data available in sales operations be used in the promotion strategy\n\nRequirements:\nDemonstration of good written and verbal communication skills\nPrefer background and/or interest in web development and digital media\nAbility to work in a dynamic environment\nMarketing focus\n\n\u2022 Origination of Marketing materials on the Sales Order website and Global sharing website\n\u2022 Digital strategy for Stellaris and Stellaris PC websites (or webpages on Bausch.com)\n\u2022 Understanding of data to be used in promotion\n\u2022 High School diploma required. Current student in 4 year degree program.\n\u2022 Proficiency with Microsoft Office tools\n\nJob: Marketing", "date_new": "2012-05-05 19:45:32", "url": "http://bausch.jobs/xml/28466751/job", "country": "United States", "company": "Bausch + Lomb", "title": "Marketing Intern \u2013 Equipment Marketing", "reqid": "00007695", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28466751}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Marketing Intern \u2013 Femtosecond Laser\nLocation: United States-California-Aliso Viejo Site\n\nPOSITION SUMMARY:\nThe Marketing Intern \u2013 Femtosecond Laser will be responsible for working with the Marketing team for 8-10 weeks during the summer of 2012 in a temporary role. This internship will focus on several meaningful projects aimed at advancing Bausch  Lomb\u2019s business objectives as well as providing the intern valuable, hands-on business experience.\n\nThe ideal candidate will demonstrate a history of a high degree of accuracy and attention to detail and will be able to manage multiple projects by demonstrating a strong understanding of prioritization.\n\nPROJECTS:\n\nAssemble, organize and publish library of materials supporting the Victus laser launch, including:\n\u2022 Surgeon slide presentations\n\u2022 Surgical videos\n\u2022 Technical animations\n\u2022 Promotional sales tools\n\u2022 Training materials\n\nProject will include identification and modification of an online resource with access controls for global users. Will require communication with global team members to gather materials. Will also require interface with Medical/Legal Review process to ensure appropriate clearance for all materials by market.\n\nCreate B L Victus webpage/update TPV website\n\u2022 Work with creative agency to re-purpose approved materials for the creation of a competitive and impactful web property.\n\u2022 Work in concert with B L digital initiatives team to ensure alignment with corporate processes and procedures, working within the framework of Bausch.com and corporate branding guidelines.\n\nAssist in other creative development projects for Victus launch as needed, which may include:\n\u2022 Patient education materials\n\u2022 Practice development materials\n\u2022 Practice tools website\n\nSuccess Criteria\n\u2022 Launch of digital resource center for Victus materials\n\u2022 Launch of Victus website (or webpages on Bauch.com)\n\u2022 Successful introduction of Victus laser to the U.S. market\n\n\n\n\u2022 Demonstration of good written and verbal communication skills\n\u2022 Prefer background and/or interest in web development and digital media\n\u2022 Global perspective\n\u2022 Marketing focus\n\u2022 High School diploma required. Current student in 4 year degree program.\n\u2022 Proficiency with Microsoft Office tools\n\nJob: Marketing", "date_new": "2012-05-05 19:45:30", "url": "http://bausch.jobs/xml/28466750/job", "country": "United States", "company": "Bausch + Lomb", "title": "Marketing Intern \u2013 Femtosecond Laser", "reqid": "00007693", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28466750}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Sales Training Intern\nLocation: United States-California-Aliso Viejo Site\n\nPOSITION SUMMARY:\nThe Sales Training Intern will be responsible for working with the Sales Operations team for 8-10 weeks during the summer of 2012 in a temporary role. This internship will focus on several meaningful projects aimed at advancing Bausch  Lomb\u2019s business objectives as well as providing the intern valuable, hands-on business experience.\n\nThe ideal candidate will demonstrate a history of a high degree of accuracy and attention to detail and will be able to manage multiple projects by demonstrating a strong understanding of prioritization.\n\nPROJECTS:\nTeam member on enVista launch training team\nReview print materials and assessment for consistency and correctness\nDevelop launch packet of pre-launch training materials and materials for instructor-led launch training program\nAssist with on-site program implementation\n\nTeam member on Crystalens \"Really Smart\" training program\nReview print materials and assessment for consistency and correctness\nDevelop launch packet of pre-launch training materials and materials for instructor-led launch training program\nAssist with on-site program implementation\nDevelop \u201cshow file\u201d of training presentations for training program\nSource training materials needed for the training program\n\nCreation of sales training \"Resource Library\" cataloging/establishing a system for utilization of product sales materials\nSource and obtain all pertinent sales materials/collateral for use in sales training classes\n\nTransition of training documentation/resources to ComplianceWire from the current Surgical LMS\nReview current LMS content, make changes to content as needed, assist the Sr. Sales Training Coordinator in uploading new content to ComplianceWire\n\nSuccess Criteria\nPrint materials will be consistent and correct for the launch meetings\nPre-launch materials will be developed accurately and timely for training programs\nA functional resource library will be developed by working closely with marketing and sales training staff\nTransition of training materials to ComplianceWire will be accomplished on time and all content will be effectively uploaded\nSales training program presentations will be effectively developed and structure\n\n\u2022 Demonstration of good written and verbal communication skills\n\u2022 Ability to work in a dynamic environment\n\u2022 Strong communication skills; ability to partner cross-functionally\n\u2022 High School diploma required. Current student in 4 year degree program.\n\u2022 Proficiency with Microsoft Office tools\n\nJob: Sales", "date_new": "2012-05-05 19:45:25", "url": "http://bausch.jobs/xml/28466749/job", "country": "United States", "company": "Bausch + Lomb", "title": "Sales Training Intern", "reqid": "00007696", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28466749}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Sales Operations Intern\nLocation: United States-California-Aliso Viejo Site\nPOSITION SUMMARY:\nThe Sales Operations Intern will be responsible for working with the Sales Operations team for a period of 8-10 weeks during the summer of 2012 in a temporary role. This internship will focus on several meaningful projects aimed at advancing Bausch  Lomb\u2019s business objectives as well as providing the intern valuable, hands-on business experience.\n\nThe ideal candidate will demonstrate a history of a high degree of accuracy and attention to detail and will be able to manage multiple projects by demonstrating a strong understanding of prioritization.\n\nPROJECTS:\n1. Create a database of all ophthalmic surgeons - Gather information on the surgeon\u2019s contact information and facility relationships as B L has many different sources of data. The goal of this project would be two part:\n1. Identifying all of the different data sources and information.\n2. Uploading into SFDC for use by everyone in the Surgical division.\n\n2. Finalize licensing of all B L purchasing facilities - One of the sources of data we utilize is MedPro which contains thousands of data points for our customers and surgeons. We currently have 700 facilities that we need to review in MedPro to determine the licensing status of the facility.\n\n3. IDN and HIN/GLA Update \u2013 Updating our customer master with GPO or IDN affiliations. This will result in better reporting and increased efficiencies\n\n4. Contracts Sharepoint Update \u2013 Move all 2012 and [possibly] 2011 customer contracts and all related information by customer to Sharepoint. This is an important project as we develop our work from home plan.\n\n5. Miscellaneous activities:\na. Expired Contract/Buying Agreement communication to field\nb. Product Kit de-activation for non-used kits\n\nSuccess Criteria\n1. Database gathering will be accessible in SFDC\n2. Medpro inquiries will enable B L to validate the license status of\n3. IDN and HIN will allow for more effective decision making when reviewing customer accounts and their designated pricing.\n4. 2011 and 2012 contracts will have been successfully entered into the Sharepoint database which will enable employees to work from home due to the accessibility of information in Sharepoint.\n5. (a) Expired contracts will be updated with either a new contract or their expired price will be reverted to the non discounted price.\n(b) Product Kit information in PS will reflect the actual status of whether the Product Kit is active or inactive.\n\n\n\u2022 Demonstration of good written and verbal communication skills\n\u2022 Ability to work in a dynamic environment\n\u2022 Strong communication skills; ability to partner cross-functionally\n\u2022 High School diploma required. Current student in 4 year degree program.\n\u2022 Proficiency with Microsoft Office tools; database experience a plus\nJob: Clerical", "date_new": "2012-05-05 19:45:22", "url": "http://bausch.jobs/xml/28466746/job", "country": "United States", "company": "Bausch + Lomb", "title": "Sales Operations Intern", "reqid": "00007697", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 28466746}, {"country_short": "USA", "city": "Aliso Viejo Site", "description": "Title: Surgical Global Regulatory Affairs Director\nLocation: United States-California-Aliso Viejo Site\nThe Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lomb\u2019s Surgical products throughout their lifecycle. The position covers Equipment, Instruments and Accessories, IOLs, Inserters and Surgical Solutions.\n\nThe incumbent is responsible for the overarching global surgical regulatory strategy, and managing interactions with various regulatory authorities. Provides directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Leads Regulatory Affairs personnel associated with the Surgical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and evaluation of changes to product, process, facilities, etc.). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. The position is responsible for regulatory activities related to design, development and US/EU approval. \n\nSpecific Job Duties :\n\nServe as a leadership team member for Bausch & Lomb\u2019s Surgical Regulatory Affairs function\nOversee the development of global product regulatory strategies for all Bausch & Lomb Surgical products\nOversee the regulatory functions in relation to device design & development and product approvals, consistent with Bausch & Lomb agreed upon timelines\nManage interactions with Regulatory Authorities for Surgical products\nBuild relationships with regional and global Bausch & Lomb Regulatory Affairs teams\nProvide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections\nProvide regulatory guidance/input to internal product review boards\nSelect, develop, and motivate a regulatory team that supports personal growth and a culture of compliance\nPlay a significant role in the performance management process and career development programs for supervised regulatory personnel\nEducation & Experience\nBachelors degree in science or health related field\nAdvanced degree highly preferred (PhD, MD, MS, JD, or equivalent)\n10 years medical device industry and regulatory experience\nOphthalmic Surgical device regulatory experience highly preferred\n\nQualifications\n\nStrong capability to lead and support a collaborative team environment\nDemonstrated ability in analytical reasoning and critical thinking skills\nAbility to manage in a highly matrix organization\nDemonstrated ability to lead a multidisciplinary team\nStrong business acumen and ability to see the business drivers outside of Regulatory Affairs\nExcellent communication skills; both oral and written\nStrong interpersonal skills with the ability to influence others in a positive and effective manner\nDemonstrated ability to contribute to a continuous learning and process improvement environment\nCapacity to react quickly and decisively in unexpected situations\nDetail-oriented with the ability to proofread and check documents for accuracy and inconsistencies\nFocused ability to influence operational excellence and performance metrics\n Risk adverse where needed with the ability to identify potential solutions to complex problems\n\n\nTechnical Qualifications\nKnowledge of ophthalmic surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations\nKnowledge of domestic and international laws, regulations, and guidance\nKnowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization\nAbility to influence and partner within Bausch & Lomb Global Regulatory Affairs group and with cross-functional teams\nAbility to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval\nAbility to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data\n\nManagerial Responsibility 4Job: Regulatory Affairs", "date_new": "2011-12-14 01:15:57", "url": "http://bausch.jobs/xml/25342740/job", "country": "United States", "company": "Bausch + Lomb", "title": "Surgical Global Regulatory Affairs Director", "reqid": "00007395", "state": "California", "state_short": "CA", "location": "Aliso Viejo Site, CA", "uid": 25342740}]