Quality & Regulatory Manager

Surgilūm is hiring a Regulatory Affairs & Quality Systems Manager to assume a broad, high-impact role within a small ISO 13485-certified medical device company.

This position combines regulatory coordination, quality system administration, supplier management, purchasing oversight, incoming inspection coordination, traceability support, and selected internal systems administration. The successful candidate will help maintain operational continuity across the regulatory and quality functions while partnering closely with leadership and outside resources such as BSI and Emergo.

This is not a narrow desk role. The position requires someone who can move comfortably between quality system management, audit preparation, document control, supplier qualification, approved supplier maintenance, purchase order process oversight, incoming

inspection records, corrective action follow-up, and practical day-to-day execution. The role also touches internal systems administration, including Microsoft account continuity and operational file structure support, because the company operates with a lean team and values versatile contributors.

Core duties

- Support and maintain regulatory and quality system compliance activities in an ISO 13485

environment.

- Prepare for and support external and internal audits, maintain action-item follow-up, and

organize quality records.

- Maintain supplier qualification files, approved supplier records, supplier performance reviews, and supplier communication.

- Coordinate purchasing and procurement-related workflows, including PO process continuity and supplier follow-up.

- Oversee or coordinate incoming inspection records, nonconforming material escalation, and traceability-related documentation.

- Support operational use of inventory/build systems that connect parts usage to finished units.

- Maintain continuity in key internal systems and shared business accounts as assigned.

- Improve workflow documentation and reduce single-point-of-failure risk across the business.

Ideal qualifications

- Experience with ISO 13485 and practical quality system execution.

- Working familiarity with audits, CAPA, supplier controls, document control, and incoming

inspection.

- Strong writing, record keeping, and follow-through.

- Ability to work independently in a small-company, multi-hat environment.

- Bonus: experience with EU/consultant-supported regulatory workflows, inventory traceability systems, and Microsoft 365 administration.

Why this role matters

This role is central to continuity in a growing med-tech company where regulatory, quality, supplier, and operational controls intersect. It offers the chance to build structure, improve systems, and become a key operational leader in a company where individual contribution has immediate impact.

Pay: $60,000.00 - $85,000.00 per year

Benefits:

• Paid time off

Work Location: In person