Group Director - Quality and Regulatory Affairs - Moog Inc. - Salt Lake City

The Medical Devices Group designs, manufactures, and distributes industry-leading enteral feeding, infusion, and post-operative pain management pumps, fluid sensing and control solutions, and surgical hand pieces. We are currently looking for a Group Director, Quality and Regulatory Affairs. This key role in our organization is responsible for ensuring regulatory and quality compliance with Federal, State and Local regulations pertaining to GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory agencies through effective management of MMDG Product Quality. The Salt Lake City, Utah facility is located at the foot of the beautiful Wasatch mountains.



Core Responsibilities
Act as liaison with 3rd party inspectors (e.g. FDA, Notified Body, customers)
Review and analyze Quality System data and report to Executive Management on the state of the Quality System; Ensure Quality System compliance to relevant regulations and standards
Provide regulatory support for Product Development and participate in regulatory planning from the beginning of a project
Participate in design reviews to ensure compliance with design control requirements, and provide internal validation services
Supervise Regulatory Affairs, including; Regulatory submissions, Maintenance of licenses, registrations, etc., Post-market surveillance activities, Corrections, removals, and recalls Medical Device Reporting, Incident Reporting
Participate in product acquisition activities, including; Review acquisition to ensure applicable quality and regulatory records are obtained, transfer regulatory registrations, etc. to ZEVEX, participate in acquisition project to evaluate any design changes or changes in market location that could lead to regulatory submission changes
Manage Quality Organization: Work with Quality Manager, Quality Technicians, Quality Engineers and Document Control Specialist to perform their duties in support of company objectives. Provide clear objectives and goals to the Quality group, and measure progress toward goals
Supervisory Responsibilities: This position supervises the MDG Quality and Regulatory Managers and their direct reports.

What Talents And Abilities You Will Bring With You
Bachelor Degree, Master’s Preferred.
10+ years’ operating experience in Quality and Regulatory function in a related industry (highly preferred in electro-mechanical devices)
Proven success in mastering new concepts, applications, and incorporating them into the business plan.
Able to succeed in highly regulated compliance oriented environment while still providing service excellence
Possess knowledge and understanding of current Quality techniques and industry standards and their impact on internal procedures, quality, and safety and efficacy of products.
Thorough knowledge of ISO 13485, ISO 9001, IEC 60601, Medical Device Directive, and Canadian Medical Devices Regulations
Must have excellent verbal and written communication skills, including being able to communicate

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