Johnson & Johnson Surgical Vision (JJSV) is recruiting for an Associate Director, Regulatory Affairs in Santa Ana, CA. JJSV designs, manufactures, and distributes medical devices 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.
A minimum of 8 years of experience in all aspects of Regulatory Affairs in the Medical Device Industry is required.
Extensive hands on experience in activities such as product approval applications, crisis management such as product recalls, FDA inspections is required.
Strong understanding of Medical Device regulations / standards and Quality principles is required.
Strong written and verbal communication skills.
Ability to manage multiple priorities effectively.
Strong interpersonal and organizational and problem-solving skills.
Ability to make difficult and often unpopular decisions.
Strong negotiation skills as it relates to regulatory bodies worldwide.
Lead by example.
Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
Instill and drive a regulatory culture. Establish and support policies and standards for new products.
Develop and execute worldwide strategies for product registration, notification, or pre-market approval requirements.
Partner with WW Clinical Operations to develop clinical strategies and ensure compliance with local, state, and Federal regulations for conducting clinical trials worldwide.
Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.
Directly or through subordinate staff, develop US IDE/510K/ and PMA submissions for class II and III medical devices, and EU Design Dossiers and Technical Files.
Directly or through subordinate staff, generate documentation to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by BWI and/or J&J affiliates.
Conduct submission negotiations with the FDA as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
Maintain proficiency on regulatory requirements; develop and maintain rapport with FDA reviewers, project team members, and other stakeholders.
Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
Responsible for providing performance feedback to direct reports as well as coaching and assistance in their development.
Identify and manage departmental project and personnel issues.
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Primary Location: North America-United States-California-Santa Ana