VP of QA and Regulatory Affairs – FILLED
VP of QA and Regulatory Affairs from The Wellington Group @twgrecruiters
The Wellington Group has been engaged to find a VP of QA and Regulatory Affairs to cover both the quality assurance and regulatory affairs departments of a growing medical device company. This position will develop, implement and manage the company’s quality and regulatory strategies. Put your skills and experience to work in a new position!
VP of QA and Regulatory Affairs responsibilities include:
- Direct Quality Assurance activities for sourcing of raw materials, product development, manufacturing & characterization
- Assure company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products
- Oversee Quality System activities including Documentation Control, Internal Audits, Quality Records maintenance, and Management Review
- Contribute to preparation of CMC sections for IDE and PMA submissions, and international equivalents
- Interface with US and International regulatory authorities as necessary
- Maintain regulatory procedures and documents to assure continued certification for development, manufacturing, and marketing of products
- Work in a cross-functional team and represent Quality at Product Development team meetings
- Contribute to the development and implementation of process/methods validation protocols and reports
- Audit and oversee activities of contract manufacturers, suppliers and consultants
The qualified VP of QA and Regulatory Affairs candidate will have:
- 12-15+ years experience within medical/pharmaceutical products quality and regulatory environment
- Track record of providing regulatory direction to development, pre-clinical and clinical evaluation, manufacturing, and marketing of combination products, including experience with CMC requirements
- BS in scientific or engineering discipline, advanced degree preferred
- Experience in preparing and obtaining approval of device/drug combination product FDA/ISO/CE submissions and follow-up maintenance activities for approvals and certifications
Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.