Head of QA and Regulatory Affairs | Quality Assurance Jobs in Durham | QA Jobs

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Chris

Head of QA and Regulatory Affairs

Posted on Lycos Classifieds - Over 4 weeks ago

Company:: The Wellington Group

Location:: Durham, NC

Features & Description

The Wellington Group has 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 company’s 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

Job Code: BHJOB1778_225

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com )

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