Top Echelon Network
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Job Location: Research Triangle Park, NC
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We have been engaged to find a senior manager to cover both the quality assurance and regulatory affairs departments of a growing medical device group. This position will develop, implement and manage the companys quality and regulatory strategies. Put your skills and experience to work in a new position!
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 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
Industry: Medical Device
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