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Regulatory Affairs Specialist III
Requisition ID: 2945180206
The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist III aligned to Advanced Sterilization Products, located in Irvine, CA.
The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
- Provide administrative and technical support to regulatory affairs management in order to facilitate compliance with all FDA and other U.S. and international regulatory requirements.
- Provide Regulatory support to lifecycle management and new product development cross-functional project teams, including in-depth team involvement for complex projects; evaluation of proposed product modifications for global Regulatory impact; and documentation of required change impact assessments and Regulatory Strategies.
- Coordinate, compile, and submit Regulatory documents to FDA and other Regulatory Agencies. This includes the preparation of international documents, including Technical Files.
- Work with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
- Ensure compliance with FDA and other applicable regulations and standards.
- Prepare responses to FDA questions and other Regulatory correspondence
- Work under minimal supervision, with benefit of previous regulatory experience.
- Develop solutions to a variety of problems of moderate scope and complexity.
- Participate in the development, review and approval of product labeling
- Review and approve promotional materials.
- A Bachelor’s degree and minimum of 4 years related work experience is required.
- Medical Devices experience is preferred.
- Experience with proper application of:
- Title 21 of the US Code of Federal Regulations Parts 800-1299 (21 CFR 800-1299) is required.
- US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k) is required.
- European Medical Devices Directive (93/42/EEC as amended by 2007/47/EC) is required.
- Quality Management System Standard ISO 13485 is required.
- Risk Management Standard ISO 14971 is required.
- International Medical Device requirements (China, Japan, Canada, Australia, Brazil, Russia, etc.) is required.
- Excellent written and oral communication skills are required.
- Good analytical thinking, problem solving and investigative skills are required.
- Proficiency in Microsoft Office and related applications is required.
- This position will be located in Irvine, CA 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.
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