[{"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\n\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: 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\n\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: 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 4\n\nJob: 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}, {"country_short": "USA", "city": "Madison Site", "description": "Title: Senior Director Regulatory Affairs\nLocation: United States-New Jersey-Madison Site\nThe major objective for this position is set the strategic direction for Regulatory activities affecting the geo-expansion. This includes but is not limited to overseeing the development of all regulatory strategies, preparation of regulatory applications, labeling, advertising and promotional review, and life cycle management for the pharmaceutical division. The primary goal of this project is to meet the deadlines and yearly goals for regulatory submissions as established for the pharmaceutical division. It is expected that the targeted yearly submission numbers are met and/or exceeded.\n\nA critical subtask is to oversee health authority liaison activities for all global geo-expansion submissions. Work with the local regulatory representatives to ensure proper activities with the appropriate regulatory agencies.\n\nThe primary team role for the Dir, Regulatory Affairs Geo Expansion is to act as the face for the geo-expansion team for internal and external stakeholders. You will set the regulatory direction by proactively developing new and innovative approaches for pursuing business objectives within regulatory frameworks. The Dir, Regulatory Affairs Geo Expansion will work closely with a diverse, cross-functional team consisting of clinical operations, biostatistics, pharmacovigilance and safety. As part of this team effort, the person will actively be involved in multiple projects and provide constant leadership and direction throughout the whole process.\n\nThis is your chance to expand your growth opportunities by providing leadership to a company initiative that will have a very strong impact on the pharmaceutical business unit. This role while very hands on will be instrumental in the development and evolution of this Regulatory group. Part of your development in this role will involve providing continuous strategic insight for the projects for both in licensing and existing products.\n\nSpecific Job Duties:\n\n\u00b7     Sets the regulatory direction by proactively developing new and innovative approavhes for pursuing business objectives within regulatory framework.\n\n\u00b7     Lead regulatory geo-expansion staff on a global level and ensure close collaboration with the regional regulatory representatives throughout the world.\n\n\u00b7     Set direction and strategy for global health authority meetings regarding Bausch  Lomb Pharmaceutical products\n\u00b7     Candidates must be recognized as a regulatory expert internally and externally with in-depth knowledge of the global regulatory environment affecting the industry with a proven track record of taking products through to completion.\n\n\u00b7     They must also have solid business acumen with the ability to work effectively across diverse functions and levels within the company and understand the key interdependencies required to develop and market pharmaceutical products on a global level.\n\n\u00b7     Must have 15 years of global regulatory affairs experience. Experience with Ophthalmics is a plus.\n\n\u00b7     Advanced degree preferred (Ph.D, MBA, PharmD, JD, MD)\n\nManagerial Responsibility:\n\nThere are currently 11 contractors globally that this person will be managing directly.\n\nJob: Regulatory Affairs", "date_new": "2011-09-27 21:25:06", "url": "http://bausch.jobs/xml/23876967/job", "country": "United States", "company": "Bausch + Lomb", "title": "Senior Director Regulatory Affairs", "reqid": "00007255", "state": "New Jersey", "state_short": "NJ", "location": "Madison Site, NJ", "uid": 23876967}]