Responsible for preparing regulatory submission materials for agency review and approvals. Research the latest regulatory FDA requirements and provide guidance to PSGs on inputs required for submissions.
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.
Provide consultation to projects on submission requirements related to product developments. Provide Project Leaders with submission plans and strategies related to FDA device clearance.
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.
• EDUCATION: Bachelors degree in Bio Engineering or Science and Masters or PhD is preferred