Director of Quality Assurance/Regulatory Affairs

We are seeking a Director of Quality Assurance/Regulatory Affairs to contribute to the growth and sustainability of Hamilton Medical by ensuring quality levels of the Company's products conform to Hamilton Medical, regulatory, and customer standards at optimum cost while ensuring compliance with all regulatory requirements.

Requirements

• Expert knowledge of Medical Device Regulatory Requirements (U.S. FDA, EU, and other applicable global agencies)
• Strong and credible reputation with peers, with the FDA and other regulatory agencies, with customers, and with registrars
• Proven track record of authoring, reviewing, and approving high-quality 510(k) submissions

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Paid vacation time
• Paid sick time
• Disability insurance
• 401k
• Tuition reimbursement