Senior Quality & Regulatory Affairs Consultant

+ Provide Quality and/or Regulatory consulting services, independently or with oversight by a Lead QA/RA Consultant or Consultant Manager, which may include but are not limited to: Leverage regulatory affairs experience gained in the medical device industry/medical device consulting to provide client support with Quality Assurance and Regulatory compliance requests, help resolve client issues, and respond to market-specific inquiries.

+ Prepare/review local or international regulatory submissions e.g., MFDS, FDA 510(k) for or on behalf of manufacturers, demonstrate and share knowledge of requirements by market and compile/review technical documentation files for compliance to applicable regulations; raise concerns where any are identified, provide guidance for resolution.

+ Perform research on regulatory affairs requested for standard or nuanced market environments and generate peer reviewed reports.

+ Provide Quality Assurance consulting services, s...