Quality Assurance and Regulatory Affairs Lead
Manufacturing · Great Lakes

Quality Assurance and Regulatory Affairs Lead (Medical Device exp req) Location: Ann Arbor, Michigan Salary: $110,000 - $130,000 + Stock Options + Benefits Benefits: Medical, Dental, Vision, 401k w/3% Match, PTO, Holidays, Start Date: ASAP Job Type: Full-Time Travel: 15-20% (Domestic) Typical Hours: M-F, Core hours – 9am – 4pm flexible Sponsorship not available Relocation Assistance Available Quality Assurance and Regulatory Affairs Lead (Medical Device exp req) Our client in the medical device industry is looking for a Quality Assurance and Regulatory Affairs Lead to add to their team. Reporting directly to the CEO, you will identify, plan, and implement the policies and procedures within the business, while ensuring compliance with medical device regulatory standards through the development process and ongoing quality/regulatory compliance in manufacturing. The ideal candidate will be highly motivated and passionate about developing new products. Quality Assurance and Regulatory Affairs Lead Responsibilities (Medical Device exp req) • Assist in developing a vision for the Quality organization and translate that into operating plans and actions to ensure complete customer satisfaction and financially sound business growth • Establish and implement quality plans and systems for new product approval/clearance and ensure ongoing operational and quality compliance • Establish and complete new product / existing product manufacturing and quality engineering activities • Assist with regulatory submissions, including 510(k) and CE Marking, Investigational Device Exemption (IDE), and other applications (i.e. Premarket Approval Applications (PMA)) • Perform labeling reviews and approvals for quality and regulation compliance • Perform supplier qualification and ongoing monitoring to verify compliance with requirements • Interface with quality representatives from suppliers and customers and develop corrective action plans for effective implementation • Participate in third party audits (FDA, Notified Body) of the Quality System Quality Assurance and Regulatory Affairs Lead Qualifications (Medical Device exp req) • Bachelor’s degree in Manufacturing / Quality Engineering or related field required • 3+ years of quality assurance experience required • 3+ years of working in the Medical Device industry experience required • 1+ years of medical device regulatory requirements, (ISO 13485:2016) experience required • 1+ years of creating submissions experience required • 1+ years of First- and Second-Party auditing experience is highly desirable • 1+ years of Quality Auditor or Certified Lead ISO Auditor experience preferred