Johnson & Johnson's Family of Companies is recruiting for a Senior Regulatory Affairs Program Lead to be located Irvine, CA (preferred) or Somerville, NJ to support our Mentor business.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast and aesthetic surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. MENTOR® is the only manufacturer whose silicone breast implants are made in the U.S.A. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.
The Senior Regulatory Affairs Program Lead will be responsible for the preparation of regulatory submissions required to market new or modified medical devices in both domestic and international markets. This responsibility entails development, execution and management of procedures and systems designed to ensure that the product development process, including clinical studies, addresses all regulatory requirements and the objectives of the business.
In this role, you will:
- Prepare FDA, CE, and international submissions for high risk classification medical devices, new products and product changes, as required, to ensure timely approval for market release.
- Communicate directly with international affiliates and regulatory agency personnel.
- Create and Execute regulatory strategies/plans. Provide ongoing support to project teams for regulatory issues/questions
- Support and lead regulatory affairs projects for new and currently marketed products as necessary. This includes reviewing labeling, post-market activities, and meetings with Health Authorities (FDA, HealthCanada, TGA etc.)
- Provide support to Product and Manufacturing changes as necessary. This requires development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers.
- Ensure regulatory affairs files are maintained to support compliance with regulatory requirements, including internal and external audits.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedure.
- Perform Copy Review for internal and external facing documentation to ensure compliance with applicable Federal, State, local and Company regulations, policies, and procedures
- Other responsibilities as required or assigned by manager.
- A minimum of Bachelor’s degree is required with at least 5 years of related regulatory affairs experience in a health regulated industry experience is required
- A scientific or technical degree is preferred
- An advanced degree is preferred
- Demonstrable knowledgeable of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical device is required, previous experience with class III medical devices is preferred
- Previous experience interacting directly with FDA is required
- Previous experience interacting with international Health Authorities is preferred
- Previous experience updating technical files and design dossiers is required
- Previous experience creating and submitting change notifications to regulatory agencies is required
- Previous project management/ project lead experience is preferred
- Previous experience conducting Copy Review of Advertising & Promotional Materials is preferred
- The willingness and ability to be located in either Irvine, CA or Somerville NJ 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
North America-United States-New Jersey-Somerville
Medical Device Business Services, Inc (6029)