Sr. Regulatory Affairs Program Lead

Sr. Regulatory Affairs Program Lead - 2206082218W
Description
At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Senior Regulatory Affairs Program Lead (Specialist IV) in Santa Ana/Irvine, CA or REMOTE for the right candidate (in the US). JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
The Senior Regulatory Affairs Program Lead (Specialist IV) will provide regulatory support in any number of areas: help develop regulatory strategies for new product development initiatives, regulatory assessment of NPI (New Product Introduction) and LCM (Life Cycle Management) projects to help determine the appropriate regulatory pathway, lead FDA interactions, execute regulatory submissions, and respond to questions from global Agencies to expedite market access, review/approve labeling, advertising & promotional materials, process improvement and database maintenance and support internal external audits.
This position is within the Cataract Implants Product Portfolio team which includes support for Intraocular Lenses (IOL), Ophthalmic Viscosurgical Devices (OVDs), and other accessory devices.
In this role, you will:
- Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
- Participate in the design and conduct of clinical trials, including leading efforts to obtain and maintain the appropriate regulatory approvals from the FDA, IRBs and/or Ethics Boards.
- Lead FDA interactions including in-person meetings, teleconferences, and other Agency communications as needed.
- Define and execute regulatory approval programs, with focus on the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, etc.
- Create global regulatory strategy to expedite new product introduction to the markets.
- Research, collect data, and respond to requests from regulatory agencies to prepare and submit documentation for marketing approvals (US, Canada and EU), as well as to provide routine regulatory information to associates and affiliates.
- Continually improve internal regulatory processes and procedures to increase efficiency and reduce time to market while maintaining the highest levels of compliance and maintain databases as required.
- Evaluate manufacturing changes, conduct and collect global regulatory assessments, and author submissions, including PMA annual reports and supplements as needed.
- Prepare regulatory labeling requirements for new and modified product.
- Review product labeling, advertising and promotional materials for existing products to ensure compliance.
- Provide Regulatory Affairs support during internal and external audits.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Qualifications
- BS or an advanced degree in technically related field (science or engineering) is required.
- A Bachelor's degree with at least 6 years of related regulatory affairs experience OR an advanced degree with at least 4 years of related regulatory affairs experience in the health care industry is required.
- Previous experience with class III medical devices and design control principles is required
- PMA/PMA Supplement filing experience required.
- Experience in direct FDA interactions including premarket notifications, IDE's, Q-submissions and in-person meetings preferred
- Previous experience updating technical files/documentation and design dossiers is preferred.
- RAC certification a plus
- Previous experience conducting Copy Review of Advertising & Promotional Materials is preferred.
- Strong communication, organizational, negotiation and interpersonal skills is preferred.
The position will be based in Santa Ana/Irvine, CA or remote for the right candidate (in the US) with up to 10% travel is required.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Primary Location NA-US-California-Irvine
Other Locations NA-United States
Organization Johnson & Johnson Surgical Vision, Inc (6234)
Job Function Regulatory Affairs
Req ID: 2206082218W