Our client is seeking a Senior Regulatory Affairs Specialist for their West Chester, Pennsylvania location to support new, modified, and currently marketed medical devices.
- Position will represent regulatory affairs on product development teams and provide the global regulatory plan, regulatory assessments, and regulatory decisions.
- Prepare regulatory documentation for devices, including IDE, 510(k), PMA, Technical File/Technical Documentation and Design Dossier documentation 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.
- Position will assist in the preparation of approval documents to support rest of world registrations/approvals.
- 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.
- Assist with the maintenance of the regulatory database(s) with accurate and current regulatory information.
- Provide Regulatory Affairs support during internal and external audits.
- Provide regulatory support during product nonconformance (NC) investigations and Corrective and Preventive Action (CAPA) activities.
Qualified applicants will have a Bachelor degree in a science or engineering field and 4 years of regulatory affairs experience in medical devices or a Master’s degree plus relevant medical device industry experience.
Experience must include: FDA medical device regulations and guidance, including unique device identifier (UDI) regulatory requirements; EU MDD/MDR medical device regulations and guidelines; orthopaedic implants; Canadian regulations and guidance, and MDALL database; electronic submission preparation; regulatory assessments for product changes; review of marketing/promotional materials; support for NC, CAPA, and audit related activities.
A qualified applicant will possess experience with the following software and database systems: MS Office (Word, Excel, PowerPoint); Adobe Acrobat (full version, 9 or above); Agile PLM System; Windchill PLM System; JDE database; copy approval systems; FDA FURLS database; and GMDN database.
Up to 10% international and domestic travel may be required.