Vice President Regulatory Affairs

Pragmatic; Bedford (MA); Hybrid; USD 266,000 - 326,000; Full time

Job summary

A leading medical device company is seeking a VP of Regulatory & Quality in Bedford, MA. This pivotal role involves shaping regulatory strategies and ensuring compliance with global standards. The ideal candidate will have extensive experience in regulatory affairs, strong leadership skills, and a collaborative approach to cross-functional teamwork. Join a dynamic environment where your expertise will directly impact patient outcomes and company growth.

Qualifications

• 7–15 years of experience in regulatory affairs and quality assurance.
• Proven track record with U.S. and global regulatory submissions.

Responsibilities

• Lead and execute global regulatory strategies.
• Provide leadership and oversight to an internal quality team.
• Collaborate cross-functionally with R&D, Clinical, and Operations.

Skills

Leadership

Decision-Making

Communication

Job description

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VP or Head of Regulatory & QualityLocation: Bedford, MA (Hybrid, 4 days on site, 1 day remote)Industry: Medical DeviceEmployment Type: Full-time | Competitive Compensation & Benefits
About the CompanyOur client is an innovation-driven medical device company focused on developing and commercializing technologies that impact patient outcomes. Backed by a strong platform of portfolio companies, we operate with the agility of a startup and the resources of a well-capitalized organization. Our leadership is experienced, pragmatic, and deeply committed to building a culture of quality, execution, and smart collaboration.
This is an opportunity to shape the regulatory and quality function at a pivotal time in the company’s growth, with real ownership, impact, and visibility.
ResponsibilitiesLead and execute global regulatory strategies, including 510(k), IDE, and PMA submissions.Act as primary contact with regulatory authorities and manage agency interactions, audits, and submission reviews.Provide leadership and oversight to an established internal quality team; ensure continued compliance with FDA, ISO 13485, MDSAP, and global regulations.Collaborate cross-functionally with R&D, Clinical, and Operations to integrate regulatory and quality input throughout the product lifecycle.Serve as Deputy Management Representative and support internal and external audit readiness.Develop scalable frameworks to guide regulatory and quality functions across future products and affiliated entities.
Qualifications7–15 years of experience in regulatory affairs and quality assurance within the medical device industry.Proven track record with U.S. and global regulatory submissions, including PMA and 510(k).Familiarity with QMS compliance standards including cGMP, ISO 13485, CMDR, and MHLW MO 169.Experience in early-stage or small company environments, with a willingness to be hands-on.Strong leadership, decision-making, and communication skills.
Why Consider This Role?Step into a senior leadership role with direct influence on strategy and execution.Work in a cross-functional, collaborative team where regulatory leadership is truly valued.Gain broad visibility across product development, quality systems, and future growth initiatives.Join a company with strong institutional support, but without the bureaucracy of a large organization.
If you’re ready to help shape a regulatory and quality function from the inside out—and want your work to have real impact—we’d love to hear from you. All inquiries will be handled confidentially.

Seniority level

• Seniority level

  Executive

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Quality Assurance, and Other

• Industries

  Medical Equipment Manufacturing

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