Johnson & Johnson's Family of Companies is recruiting for a Manager, Regulatory Affairs to support our Mentor Franchise within Medical Companies. The position can be based in either Irvine, CA; Somerville, NJ; London, England; Leiden, Netherland; Brussel, Belgium or remote in the corresponding countries for the right candidate.
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.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Manager, Regulatory Affairs 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 and international submissions for new products and product changes, as required, to ensure timely approval for market release. Communicate directly with international affiliates and regulatory agency personnel.
Execute regulatory strategies/plans. Provide ongoing support to product development teams for regulatory issues/questions.
Provide support to new and currently marketed products as necessary. This includes reviewing labeling, promotional material, and other post-market activities.
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.
Support internal and external audits by regulatory agencies as required.
Carries 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.
Be responsible for ensuring that direct reports follow all company guidelines related to Health, Safety and Environmental practices
Be responsible for providing performance feedback to direct reports as well as coaching and assistance in their development.
Assist in the identification and management of departmental project and personnel issues.
Be responsible for communicating business related issues or opportunities to next management level.
Be 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.
A bachelor’s degree and a minimum of 8 years of related experience OR A master’s degree and a minimum of 6 years of related experience OR A Ph. D. degree and a minimum of 4 years of related experience is required.
Demonstrable knowledge of FDA, EEA Health Regulations 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 in the development of regulatory strategies 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 position can be based in in either Irvine, CA; Somerville, NJ; London, England; Leiden, Netherland; Brussel, Belgium or remote in the corresponding countries for the right candidate 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.
United States-California-Irvine-31 Technology Dr Other Locations
United States, Belgium, United Kingdom, United Kingdom-England, Belgium-Brussels-Capital Region-Brussels, United Kingdom-England-London, Netherlands-South Holland-Leiden, United States-New Jersey-Somerville Organization
Medical Device Business Services, Inc (6029) Job Function
Regulatory Affairs Requisition ID
Open Positions from Johnson & Johnson Family of Companies