Johnson & Johnson Careers
Regulatory Affairs Manager – Mentor
Requisition ID: 9550181210
Johnson & Johnson's Family of Companies is recruiting for an Regulatory Affairs Manager to be located in Irvine, CA 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.
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 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.
You 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.
You, the Regulatory Affairs Manager 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.
• Responsible for ensuring that direct reports follow all company guidelines related to Health, Safety and Environmental practices
• 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.
• Responsible for communicating business related issues or opportunities to next management level
• 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 bachelor’s degree and a minimum of 8 years of related experience is required.
• An advanced degree is preferred
• Knowledgeable in FDA,EU health regulationsand other international regulations pertaining to the design, manufacture and commercialization of medical devices is required.
• Previous experience development of regulatory strategies, creating and submitting change notifications to regulatory agencies, updating technical files and design dossiers is preferred
• Previous experience reviewing labeling, promotional material is preferred
• Previous experience supporting internal and external audits by regulatory agencies is preferred
• Computer skills, including proficiency with Microsoft Word, Excel, PowerPoint and Project are required.
• Direct experience in medical device regulatory affairs is required.
• Direct experience as People manager is preferred.
• This position will be located in Irvine, CA or Somerville NJ and may require up to 10% domestic and/or international travel.
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.
Mentor Worldwide LLC (6177)