Review and approve applicable document change orders.
Assist management in developing strategic regulatory approaches for new product/business development.
Oversee the day-to-day activities related to the quality and safety of the Company's medical device manufacturing of a commercial stage, human tissue based product.
Establish and assist with the implementation of quality systems and system improvements.
Qualifications
BA or BS in the life sciences or a related degree program
5+ years in a role with extensive quality experience in an FDA-regulated environment, with knowledge of commercial-stage medical devices.
Direct experience with tissue-based products is preferred.
Experience successfully interfacing with accreditation and regulatory agencies (ISO,FDA), writing responses and other documents required in a regulated environment.
Applications without resumes attached will not be considered.
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