Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Project Manager, Regulatory Affairs in Milpitas, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient's lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops. Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
The primary responsibility of this individual is to provide independent regulatory guidance to new product development and Value Stream teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches including defining data and information needed for regulatory approvals in conjunction with cross-functional business partners.
You, the Project Manager, Regulatory Affairs will:
Be responsible for providing regulatory guidance to project teams and will be responsible for assessing device/manufacturing changes, developing regulatory strategies and writing/coordinating/compiling and submitting regulatory documents to FDA and other Regulatory Agencies.
Documents to include PMAs, PMA Supplements/ Amendments/Annual Reports, 510(k)s, IDEs, Change Notifications, Technical Files/Design Dossiers (CE Mark) and responses to regulatory agencies' questions and other correspondence.
Act as regulatory liaison to U.S. Food & Drug Administration for Annual Reports and other regulatory submissions.
Require extensive collaboration with colleagues in other functions to ensure team objectives and milestones are met in a timely manner.
Ensure compliance with regulatory agency regulations and interpretations.
Develop timelines for submissions under the direction of senior regulatory affairs staff.
Develop solutions to a variety of problems of high scope and complexity.
Participate in the development, review and approval of product labeling.
Perform other duties as assigned by the manager of this position.
A Bachelor's Degree and a minimum of 6-8 years related work experience in the medical device industry is required.
Knowledge of Title 21 of the US Code of Federal Regulations (21 CFR 800-1299) is required.
Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required.
Experience with European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required.
Experience with of Quality Management System Standard ISO 13485 is required.
Experience with Risk Management Standard ISO 14971 is required.
Knowledge of International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is preferred.
Excellent written and oral communication skills are required.
Good analytical thinking, problem solving and investigative skills are required.
Proficiency in Microsoft Office and all related applications is required.
This position will be located in Milpitas, CA and may require up to 20 % domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Primary Location: North America-United States-California-Milpitas