Website Johnson & Johnson
The Senior Regulatory Affairs Associate is also responsible for the review and approval of all device labelling and product support information used in the promotion and educational activities of DePuy Synthes products for compliance with global regulations and company policies and procedures! In conjunction with other functions, they support post-market surveillance and vigilance activities and provide support for external and Internal audits
- Prepare and submits regulatory documentation for DePuy devices, including IDE, 510(k), PMA, Design Dossier, and Technical Documentation files for submission to regional Health authorities. This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase.
- Understands, incorporates and complies with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- Assist in the preparation of approval documents to support the rest of the world registrations, such as EU CE marking activities, as required.
- Review engineering changes to currently marketed products and prepare internal regulatory assessments for documenting decisions to submit or not to submit in accordance with relevant regulations and guidance.
- Review product labeling and product support information for currently marketed products to ensure that product information and claims are consistent with premarket clearances and approvals and in compliance with relevant regulations and guidance.
- In conjunction with other functions supports post market surveillance and vigilance activities and provide support for external and Internal audits.
- Maintain current knowledge to ensure compliance to the applicable regulatory and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards and presiding Medical Device Regulation, ISO 13485, previous MDD, MDR, etc.).
- Provide support and advice to company colleagues, particularly product development, concerning CE marking and other world regulatory requirements.
- Minimum of a B.A./B.S. or equivalent is required.
- Minimum of 4 years plus prior relevant regulatory affairs or experience in medical devices, preferred
- Demonstrated track record of formulating and executing global regulatory strategies in support of strategic business objectives is required.
- Practical experience with the preparation and submissions for Class II and III medical devices (EU)
- Substantial experience of EU and International Regulations required and knowledge of International Regulations in China, Japan, Australia, and NZ preferred
- Knowledge and/or Familiarity of U.S. FDA and EU Medical Device Regulations MDR (and previous MDD) and presiding guidance’s and standards
- Knowledge of orthopaedic devices and a proven track record of electronic preparation and submission to Health Authorities a must
- Excellent written and oral communication skills and the ability to handle multiple tasks and be detail-oriented
- Experience working with professional and trade associations
- Significant Regulatory experience covering Medical Devices and/or Drug-Device combination products
- Experience with animal-derived materials experience
- Possess computer competency in Microsoft office software, data collection and general analysis tools
Company: Johnson & Johnson
Vacancy Type: Full Time
Job Location: London, England, UK
Application Deadline: N/A