Provide Project Leaders with submission plans and strategies related to FDA device clearance. Prepare agency submission or non-filing justification for product releases. The Regulatory Affairs Medical Device Pharmaceuticals Representative will prepare regulatory submission materials for agency review and approvals.
Research the latest regulatory FDA requirements and provide guidance to PSGs on inputs required for submissions. Provide consultation to projects on submission requirements related to product developments. Collect all necessary documents for agency submissions from assigned project participants. Review all collected and prepared submission materials and ensure information is accurate and comprehensive in support of submission requirements.
Requirements: 5+ years experience in Regulatory Affairs for a medical device or pharma company. Strong knowledge of current and proposed FDA medical device regulations guidance and export requirements, experience making submissions to the FDA. Self motivated with a strong ability to lead influence negotiate and work with company and regulatory staff.
Ability to write clear concise and well-thought out technical documents.
• EDUCATION: BS degree is required preferably in Engineering or Science. A Masters or PhD is preferred.