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. Develop of regulatory strategies and regulatory submissions consistent with state federal and international requirements. Provide consultation to projects on submission requirements related to product developments.
Provide Project Leaders with submission plans and strategies related to FDA device clearance. Collect all necessary documents for agency submissions from assigned project participants. Prepare agency submission or non-filing justification for product releases. Review all collected and prepared submission materials and ensure information is accurate and comprehensive in support of submission requirements. This position is for a seasoned professional serious about taking that next step in their career.
Requirements: Minimum of 5+ years experience in Regulatory Affairs for a medical device company. Strong knowledge of current and proposed FDA medical device regulations guidance and export requirements. Experience making submissions to the FDA.
• EDUCATION: BS degree is required preferably in Engineering or Science Masters or PhD is preferred.