J&J Family of Companies Senior Regulatory Affairs Specialist III in Warsaw, Indiana
The Senior Regulatory Affairs Specialist III is responsible for regulatory activities to support new, modified and currently marketed medical devices in the DePuy Joint Reconstruction portfolio! This includes the preparation of regulatory documentation for submission to regulatory authorities (e.g., IDE, 510(k), PMA, Design Dossiers, and Technical Documentation) or internal regulatory assessment documentation.
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.
To be aware of progress and developments of worldwide regulatory requirements.
To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
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
Preferred Knowledge, Skills and Abilities:
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
Location Primary: Leeds, UK
North America-United States-Indiana-Warsaw, Europe/Middle East/Africa-Ireland-Cork-Cork
Depuy Int'l Ltd. (8722)
J&J Family of Companies
- J&J Family of Companies Jobs