Director of QA/RA - Medical Device - Bedford, MA

This role leads all regulatory affairs and quality assurance functions, ensuring global compliance and driving continuous improvement across the organization. You'll oversee submissions, audits, QMS strategy, and partner closely with executive leadership on regulatory direction.

Client Details

Our client is a fast‑growing medical technology company developing advanced solutions used in interventional procedures worldwide. They combine engineering, clinical insight, and innovation to improve patient outcomes and support physicians with cutting-edge tools.

Description

• Direct and grow the RA/QA teams while ensuring compliance with global medical device standards and regulations.
• Strengthen and optimize the Quality Management System aligned with ISO 13485, FDA QSR, and international frameworks.
• Lead internal quality audits and manage all external inspections from regulatory bodies and customers.
• Own the creation and maintenance of regulatory submissions, including MDR documentation, 510(k)s, and international market approvals.
• Oversee complaint handling, MDR/Vigilance reporting, recalls, and import/export compliance activities.
• Drive supplier quality programs and ensure vendor adherence to regulatory expectations.
• Lead validation strategy (IQ/OQ/PQ) to ensure consistent, compliant product manufacturing.
• Provide regulatory guidance for new product development, design updates, and lifecycle planning.
• Act as the primary contact for regulatory authorities, notified bodies, and external partners.
• Manage daily RA/QA operations including CAPA, risk management (ISO 14971), document control, training, and quality metrics.
• Advise senior leadership on regulatory strategy, risk, and quality performance.

Profile

• Bachelor's degree in engineering or a scientific discipline; advanced degree preferred.
• 8+ years in global medical device RA/QA, including FDA and EU regulatory environments.
• At least 5 years of medical device quality experience with deep expertise in ISO 13485 and FDA QSR.
• Proven success preparing and managing 510(k), EU MDR, and other regulatory submissions.
• Strong communication and leadership skills with experience in fast‑paced, cross‑functional teams.
• Skilled in regulatory audits, technical writing, and managing complex projects.
• Ability to collaborate across R&D, Operations, Clinical, and Manufacturing.
• Willingness to travel 10-25% as needed.

Job Offer

• Make a direct impact in a mission‑driven company improving patient outcomes.
• Lead regulatory and quality strategy for a growing, globally expanding organization.
• Work on cutting‑edge medical technologies in a collaborative, cross‑functional environment.
• Benefit from competitive compensation, strong benefits, and development opportunities.
• Join a culture focused on innovation, excellence, and continuous improvement.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.