Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Principal Regulatory Affairs Specialist in Santa Ana or Milpitas, CA or Jacksonville, FL. 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 Principal Regulatory Affairs Specialist will be responsible for administering day-to-day Regulatory Affairs department activities. The Manager combines knowledge of scientific, regulatory and business issues to enable JJSV products to meet required legislation, will have department/site level influence and be generally recognized as an expert resource within the department. The role encompasses identifying emerging regulatory issues, analyzing broad scope implications of changing regulations and guidance to provide direction to product development and lifecycle management teams. The Principal Specialist will identify data needed, work with cross functional partners to obtain these data and ensure that they are effectively presented for the maintenance of product registrations worldwide. Utilize technical regulatory skills to propose strategies on complex issues.
In this role, you will:
- Evaluate proposed and upcoming changes in the global regulatory environment to determine and communicate impact to existing or proposed products as well as overall business impact.
- Provide regulatory guidance and direction, inclusive of potential risks, to business partners and company leadership.
- Act as chief contact for global regulatory agencies a variety of projects.
- Provide regulatory guidance and oversight to product lifecycle and manufacturing functions.
- Provide guidance on regulatory issues related to advertising, labeling, public disclosures, and corporate communications.
- Collaborate and partner with medical affairs, R&D, marketing, and quality to ensure a consistent regulatory approach to global regulators.
- Assure timely regulatory clearances/approvals.
- Build relationships and systems to facilitate global product registrations.
- Advise leadership on regulatory competencies and skills needed for future regulatory team success.
- Direct interaction with regulatory agencies as needed, including pre- and post-submission discussions and negotiations.
- Work collaboratively with regulatory and cross-functional business partners to achieve and maintain compliance with regulatory requirements.
- Creatively identify risk-based solutions and strategies for problem solving.
- Perform copy review for internal and external facing documentation to ensure compliance with applicable regulations, standards, policies, and procedures.
- Guide teams in the coordination and submission of regulatory documentation to FDA, Notified Bodies, Health Canada and other regulatory agencies.
- Participate in and support internal and third-party audits.
- Provide support and input to ensure achievement of compliance-related objectives.
- A minimum of a Bachelor’s degree in scientific discipline is required. Advanced degree is preferred.
- A minimum of 8 years of regulatory related experience in a regulated industry with a Bachelor’s degree is required, or Masters and 6 years, or PhD and 4 years’ experience.
- Previous experience with US and EU medical device regulations is required. Experience with Canadian regulations is preferred.
- Experience with the preparation, submissions and approval for medical devices is required.
- Experience with software-driven electromechanical medical devices is preferred.
- Strong communication, organizational, negotiation and interpersonal skills is preferred
- Expert knowledge, understanding and application of principles concepts and practices of government regulations and applicable standards (e.g. IEC 60601-1 and ISO 14971) is preferred
- Ability to organize and analyze technical data and identify issues or gaps is preferred
- Demonstrated skills in area of staff support and development (directly or indirectly) is preferred
- Foundational regulatory knowledge to maintain legal status of products and minimize risk is preferred.
- Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, Marketing, Clinical Research etc.) and ability to effectively negotiate and influence upper management, affiliates, and Regulatory agencies are a plus.
- Self-motivated and committed to a team approach.
- Ability to travel; may require up to 25% domestically and/or internationally.
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.
United States-California-Santa Ana-
North America-United States-Florida-Jacksonville, North America-United States-California-Milpitas
Johnson & Johnson Surgical Vision, Inc (6234)