Seeking an experienced medical device or pharmaceutical Quality Assurance & Regulatory Director to fill a key management role!
This positions entails expertise in a wide range of Quality Assurance & Regulatory aspects including:
- Directing the overall QA activities for the manufacturing of dental and medical devised in an FDA/ISO 13485/Canada regulatory environment.
- Directing and overseeing the development and registration of new products produced in local plant and Germany (products sold in the US or Canada; Canada registrations, FDA registrations, ISO registrations/validations).
- Managing the Quality System and software application for the division.
- Coordination of Quality and Regulatory activities between the division and Germany (parent company).
- Creating and submitting documents to the regulatory bodies for new products, audit follow up, general updates, etc.
- Identifying and managing product complaints and disposition (ie. corrective actions, recalls, etc).
Qualified candidates must have a BS degree in Science/Chemistry, MBA preferred and a minimum of seven years experience in the Regulatory/Quality Assurance management areas, preferably with a medical device or pharmaceutical
manufacturer. Requires strong leadership, organizational, communication, problem solving, and computer skills; attention to details and ability to multi-task in a fast-paced environment is a must.
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