Bausch + Lomb Jobshttp://bausch.jobs2012-05-22 04:44:49.323481USAAliso Viejo SiteTitle: Sr. Product Surveillance Specialist Location: United States-California-Aliso Viejo Site Receiving, evaluating, and documenting information on all domestic and international complaint files Must be able to make adverse event reporting determinations to meet FDA, ISO and international regulatory requirements Must be able to file regulatory reports to appropriate regulatory agencies Ability to interact with Quality Assurance, Engineering, and others as required to address DHR review, root cause analysis and process review to prevent recurrence Duties include ability to perform data entry, create file folders, labels, letters, filing, fax, scan, and associated duties as required Contacting complainant via phone or letter to clarify or obtain additional technical information to resolve complaint Ability to interpret, follow and make required revisions to standard operation procedures required Compile, review and close complaint files Assist with projects as required Bausch 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 – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. Position requires 5-8 years of related work experience. Bachelor's degree is required (preferably in a health related field). Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, and GMPs for medical devices preferred. Position requires strong written, verbal and listening communication skills in order to interact with customers and other professionals. Candidate must be able to generate and organize clear, concise responses at different levels of management is required. Candidate must be proficient in the use of personal computer, including database management, trending and word processing. Job: Quality2012-05-15 19:56:44United StatesBausch + LombCalifornia00007711CAAliso Viejo Site, CA28707347http://bausch.jobs/xml/28707347/jobUSAAliso Viejo SiteTitle: Global Regulatory Affairs, Manager Location: United States-California-Aliso Viejo Site The 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. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for developing a global product regulatory strategy for surgical devices Responsible for obtaining and maintaining all US and EU approvals Responsible for developing and maintaining EU Tech Files and ROW Master Files Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development Develop a product regulatory timeline aligned to Bausch & Lomb’s product development, with key regulatory milestone, and activities for agency filing Coordinate with the team on the development of product labels Ensure labeling content and product documentation is developed in accordance with regulatory requirements Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions Coordinate with RA Global Expansion team to ensure timely and accurate submissions to Regulatory Authorities Act as a regulatory contact for assigned country Regulatory Authorities for surgical devices Manage interactions with other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to surgical device change control and internal product review boards TECHNICAL COMPETENCIES: Knowledge of surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices Ability to influence and partner with cross-functional teams in a global surgical organization Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks. PROFESSIONAL COMPETENCIES: Demonstrated ability in analytical reasoning and critical thinking skills Strong capability to contribute and lead a team environment Strong business acumen and ability to see the business drivers outside of Regulatory Affairs Excellent communication skills; both oral and written Strong interpersonal skills with the ability to influence others in a positive and effective manner Demonstrated ability to contribute to a continuous learning and process improvement environment Capacity to react quickly and decisively in unexpected situations Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies Focused ability to influence operational excellence and performance metrics Risk adverse where needed with the ability to identify potential solutions to complex problems Bausch 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 – from the moment of birth through every phase of life. Our mission is simple yet powerful: Helping you see better to live better. Bausch Lomb is an equal opportunity employer. 8 years relevant medical device industry and regulatory experience Ophthalmic Surgical device regulatory experience highly preferred Bachelors degree in science or health related field preferred Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent) Job: Regulatory Affairs2012-05-10 20:29:31United StatesBausch + LombCalifornia00007684CAAliso Viejo Site, CA28612454http://bausch.jobs/xml/28612454/jobUSAAliso Viejo SiteTitle: Research & Development Intern Location: United States-California-Aliso Viejo Site This technician will participate fully in surgical Intraocular Lens (IOL's) / Injector processing / testing activities on key R & D projects in development labs. Specific Job Duties Conduct IOL / Injector processing activities; lathing, milling, wet/dry processing, packaging, testing etc. as it pertains to IOL's / Injector's. Perform cosmetic, dimensional, and other forms of inspections / testing in a research environment. Set-up and operate manual, semi-automatic and fully automated research equipment, fixtures gages, etc. Assist engineers in the processing studies and validation of equipment/processes. Interface with other functional groups and peers Record and analyze test data, maintain logbooks and generate reports. Ensure adherence to protocol procedures, SOP’s, GMP’s and specifications. Be a flexible participant in cross functional teams and be able to multi task. Education: High School Diploma; some college level or job related training required Experience: 1-2 years, Medical device and/or clean room environment a plus. Special 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. Specialized 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. Job: Marketing2012-05-07 18:35:53United StatesBausch + LombCalifornia00007698CAAliso Viejo Site, CA28481704http://bausch.jobs/xml/28481704/jobUSAAliso Viejo SiteTitle: Regulatory Affairs Intern Location: United States-California-Aliso Viejo Site Bausch & 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: • Support preparation of data packages • Coordinate global regulatory assessments • Organize archived documentation • Track and communicate international approvals data • Produce draft documents for registration renewals tofacilitate the maintenance of product approvals. • Excellent writing and verbal communication skills • Some working knowledge of global device regulations • Strong problem-solving and analytical ability • Required computer skills include Microsoft Word and Microsoft Excel. • Comfortable working in a variety of corporate business management computer systems. • Background in a technical or scientific discipline such as biology, chemistry, physiology, engineering, medical or law. Job: Regulatory Affairs2012-05-07 18:35:37United StatesBausch + LombCalifornia00007699CAAliso Viejo Site, CA28481698http://bausch.jobs/xml/28481698/jobUSAAliso Viejo SiteTitle: BUSINESS DEVELOPMENT INTERN Location: United States-California-Aliso Viejo Site Bausch 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. ABOUT THE BUSINESS DEVELOPMENT TEAM: The 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’s patient-centered business strategy, and maximize the company’s position within the ophthalmic medical device industry. RESPONSIBILITIES: Interns will spend their time immersed in Bausch Lomb’s 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. Potential projects may include: • Performing market and competitor research and analysis • Supporting business case development for key acquisitions • Organizing diligence materials for acquisition targets • Ideal candidate will be pursuing an MBA from a top university with 2-4 years of work experience post business school • Experience in consulting, medical devices, investment banking, or marketing preferred • Demonstrated analytical ability • Strong communication skills • Deliverable-focused, strong work ethic • Project orientation and ability to handle simultaneous functions • Proven success in a demanding, entrepreneurial environment • Interest in medical devices/ophthalmology • Excellent attention to detail Job: Sales2012-05-07 18:35:17United StatesBausch + LombCalifornia00007700CAAliso Viejo Site, CA28481695http://bausch.jobs/xml/28481695/jobUSAAliso Viejo SiteTitle: Marketing Intern – Crystalens Location: United States-California-Aliso Viejo Site POSITION SUMMARY: The Marketing Intern – 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’s business objectives as well as providing the intern valuable, hands-on business experience. The 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. PROJECTS: Assemble, organize , and participate in the creation of materials supporting Crystalens, including: Surgeon slide presentations Surgical videos Promotional sales tools Training materials Project 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. Update and consolidate Crystalens websites: Work with web team to devise a cohesive web strategy for both consumer and professional audiences to drive utilization and awareness of Crystalens. Currently have several websites for both Professional, Consumer and Disease Education and want to maximize our web presence 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. Assemble and asses new data from for useful clinical information to support Crystalens Conduct an analysis of current data available on Surgivision DataLink to be used in the promotion and education Partner with Medical Affairs and Creative Agency to package Clinical Information for Sales Force Promotion Success Criteria Origination of Marketing materials on the Sales Order website and Global sharing website Digital strategy for Crystalens websites (or webpages on Bauch.com) Understanding of data to be used in promotion • Demonstration of good written and verbal communication skills • Prefer background and/or interest in web development and digital media • Ability to work in a dynamic environment • Marketing focus • High School diploma required. Current student in 4 year degree program. • Proficiency with Microsoft Office tools Job: Marketing2012-05-05 19:45:37United StatesBausch + LombCalifornia00007694CAAliso Viejo Site, CA28466752http://bausch.jobs/xml/28466752/jobUSAAliso Viejo SiteTitle: Marketing Intern – Equipment Marketing Location: United States-California-Aliso Viejo Site POSITION SUMMARY: The Marketing Intern – 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’s business objectives as well as providing the intern valuable, hands-on business experience. The 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. Projects: Assemble, organize , and create in a competitive landscape overview: Market analysis of cataract and retina: market size, key drivers, and differentiation Training materials Project 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. Update and consolidate Stellaris and Stellaris PC websites: Work with brand and web team to devise a cohesive web strategy for professional audiences to drive utilization and awareness of Stellaris and Stellaris PC. Currently the websites are not tied-in and/or not updated with new messaging 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. Assemble and assess sales data from for 2012 marketing strategy to support top-line growth Conduct an analysis of current data available in sales operations be used in the promotion strategy Requirements: Demonstration of good written and verbal communication skills Prefer background and/or interest in web development and digital media Ability to work in a dynamic environment Marketing focus • Origination of Marketing materials on the Sales Order website and Global sharing website • Digital strategy for Stellaris and Stellaris PC websites (or webpages on Bausch.com) • Understanding of data to be used in promotion • High School diploma required. Current student in 4 year degree program. • Proficiency with Microsoft Office tools Job: Marketing2012-05-05 19:45:32United StatesBausch + LombCalifornia00007695CAAliso Viejo Site, CA28466751http://bausch.jobs/xml/28466751/jobUSAAliso Viejo SiteTitle: Marketing Intern – Femtosecond Laser Location: United States-California-Aliso Viejo Site POSITION SUMMARY: The Marketing Intern – 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’s business objectives as well as providing the intern valuable, hands-on business experience. The 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. PROJECTS: Assemble, organize and publish library of materials supporting the Victus laser launch, including: • Surgeon slide presentations • Surgical videos • Technical animations • Promotional sales tools • Training materials Project 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. Create B L Victus webpage/update TPV website • Work with creative agency to re-purpose approved materials for the creation of a competitive and impactful web property. • 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. Assist in other creative development projects for Victus launch as needed, which may include: • Patient education materials • Practice development materials • Practice tools website Success Criteria • Launch of digital resource center for Victus materials • Launch of Victus website (or webpages on Bauch.com) • Successful introduction of Victus laser to the U.S. market • Demonstration of good written and verbal communication skills • Prefer background and/or interest in web development and digital media • Global perspective • Marketing focus • High School diploma required. Current student in 4 year degree program. • Proficiency with Microsoft Office tools Job: Marketing2012-05-05 19:45:30United StatesBausch + LombCalifornia00007693CAAliso Viejo Site, CA28466750http://bausch.jobs/xml/28466750/jobUSAAliso Viejo SiteTitle: Sales Training Intern Location: United States-California-Aliso Viejo Site POSITION SUMMARY: The 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’s business objectives as well as providing the intern valuable, hands-on business experience. The 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. PROJECTS: Team member on enVista launch training team Review print materials and assessment for consistency and correctness Develop launch packet of pre-launch training materials and materials for instructor-led launch training program Assist with on-site program implementation Team member on Crystalens "Really Smart" training program Review print materials and assessment for consistency and correctness Develop launch packet of pre-launch training materials and materials for instructor-led launch training program Assist with on-site program implementation Develop “show file” of training presentations for training program Source training materials needed for the training program Creation of sales training "Resource Library" cataloging/establishing a system for utilization of product sales materials Source and obtain all pertinent sales materials/collateral for use in sales training classes Transition of training documentation/resources to ComplianceWire from the current Surgical LMS Review current LMS content, make changes to content as needed, assist the Sr. Sales Training Coordinator in uploading new content to ComplianceWire Success Criteria Print materials will be consistent and correct for the launch meetings Pre-launch materials will be developed accurately and timely for training programs A functional resource library will be developed by working closely with marketing and sales training staff Transition of training materials to ComplianceWire will be accomplished on time and all content will be effectively uploaded Sales training program presentations will be effectively developed and structure • Demonstration of good written and verbal communication skills • Ability to work in a dynamic environment • Strong communication skills; ability to partner cross-functionally • High School diploma required. Current student in 4 year degree program. • Proficiency with Microsoft Office tools Job: Sales2012-05-05 19:45:25United StatesBausch + LombCalifornia00007696CAAliso Viejo Site, CA28466749http://bausch.jobs/xml/28466749/jobUSAAliso Viejo SiteTitle: Sales Operations Intern Location: United States-California-Aliso Viejo Site POSITION SUMMARY: The 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’s business objectives as well as providing the intern valuable, hands-on business experience. The 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. PROJECTS: 1. Create a database of all ophthalmic surgeons - Gather information on the surgeon’s contact information and facility relationships as B L has many different sources of data. The goal of this project would be two part: 1. Identifying all of the different data sources and information. 2. Uploading into SFDC for use by everyone in the Surgical division. 2. 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. 3. IDN and HIN/GLA Update – Updating our customer master with GPO or IDN affiliations. This will result in better reporting and increased efficiencies 4. Contracts Sharepoint Update – 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. 5. Miscellaneous activities: a. Expired Contract/Buying Agreement communication to field b. Product Kit de-activation for non-used kits Success Criteria 1. Database gathering will be accessible in SFDC 2. Medpro inquiries will enable B L to validate the license status of 3. IDN and HIN will allow for more effective decision making when reviewing customer accounts and their designated pricing. 4. 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. 5. (a) Expired contracts will be updated with either a new contract or their expired price will be reverted to the non discounted price. (b) Product Kit information in PS will reflect the actual status of whether the Product Kit is active or inactive. • Demonstration of good written and verbal communication skills • Ability to work in a dynamic environment • Strong communication skills; ability to partner cross-functionally • High School diploma required. Current student in 4 year degree program. • Proficiency with Microsoft Office tools; database experience a plus Job: Clerical2012-05-05 19:45:22United StatesBausch + LombCalifornia00007697CAAliso Viejo Site, CA28466746http://bausch.jobs/xml/28466746/jobUSAAliso Viejo SiteTitle: Surgical Global Regulatory Affairs Director Location: United States-California-Aliso Viejo Site The Global Regulatory Affairs Director manages all regulatory aspects of Bausch & Lomb’s Surgical products throughout their lifecycle. The position covers Equipment, Instruments and Accessories, IOLs, Inserters and Surgical Solutions. The 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. Specific Job Duties : Serve as a leadership team member for Bausch & Lomb’s Surgical Regulatory Affairs function Oversee the development of global product regulatory strategies for all Bausch & Lomb Surgical products Oversee the regulatory functions in relation to device design & development and product approvals, consistent with Bausch & Lomb agreed upon timelines Manage interactions with Regulatory Authorities for Surgical products Build relationships with regional and global Bausch & Lomb Regulatory Affairs teams Provide regulatory support to other Bausch & Lomb functions (e.g., Quality, Compliance) during Regulatory Authority inspections Provide regulatory guidance/input to internal product review boards Select, develop, and motivate a regulatory team that supports personal growth and a culture of compliance Play a significant role in the performance management process and career development programs for supervised regulatory personnel Education & Experience Bachelors degree in science or health related field Advanced degree highly preferred (PhD, MD, MS, JD, or equivalent) 10 years medical device industry and regulatory experience Ophthalmic Surgical device regulatory experience highly preferred Qualifications Strong capability to lead and support a collaborative team environment Demonstrated ability in analytical reasoning and critical thinking skills Ability to manage in a highly matrix organization Demonstrated ability to lead a multidisciplinary team Strong business acumen and ability to see the business drivers outside of Regulatory Affairs Excellent communication skills; both oral and written Strong interpersonal skills with the ability to influence others in a positive and effective manner Demonstrated ability to contribute to a continuous learning and process improvement environment Capacity to react quickly and decisively in unexpected situations Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies Focused ability to influence operational excellence and performance metrics Risk adverse where needed with the ability to identify potential solutions to complex problems Technical Qualifications Knowledge of ophthalmic surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations Knowledge of domestic and international laws, regulations, and guidance Knowledge of clinical development, including responsibilities for successful management of development milestones and global market authorization Ability to influence and partner within Bausch & Lomb Global Regulatory Affairs group and with cross-functional teams Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval Ability to support the product development team to assess whether technical arguments are presented clearly and conclusions are adequately supported by data Managerial Responsibility 4Job: Regulatory Affairs2011-12-14 01:15:57United StatesBausch + LombCalifornia00007395CAAliso Viejo Site, CA25342740http://bausch.jobs/xml/25342740/job