1 week ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Direct message the job poster from Pragmatic
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.
Referrals increase your chances of interviewing at Pragmatic by 2x
Waltham, MA $266,000.00-$326,000.00 1 day ago
Boston, MA $300,000.00-$360,000.00 4 weeks ago
Cambridge, MA $255,800.00-$401,940.00 2 weeks ago
Boston, MA $300,000.00-$360,000.00 2 weeks ago
Andover, MA $156,960.00-$215,820.00 2 months ago
Cambridge, MA $174,500.00-$274,230.00 1 week ago
Boston, MA $240,000.00-$280,000.00 2 weeks ago
Greater Boston $300,000.00-$350,000.00 4 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr...applications and computer software For additional information about driver career opportunities, please call us at 72-DRIVE (***) ***-****).... ..., or on the basis of any other federal, state/provincial or local protected class. Clean Harbors is a Military & Veteran...
...Job Summary Orthopedic Hand Surgeon Baptist Healths new Orthopedic practice is growing. Were adding an Orthopedic Hand Surgeon to our team in Fleming Island, FL. Our new orthopedic surgical team is full of dedicated staff and physicians who care for their patients...
...#Hospitality #QSR #FastCasual #Food #EntryLevel #Flexible #PartTime #DayShift #NightShift #Mornings #Evenings #EarlyBird #Overnight #McDonalds #TacoBell #ChickFilA #Culvers At MWB, we're not your typical fast food place. Our team of burger experts serve fresh, made-to-...
...required for all positionsBilingual a plus but not requiredWhat you should expect in this role On-site training at Oklahoma City, OKRemote option after 2 weeks of trainingHybrid after training unless otherwise specified by your supervisorQualified candidates may be...
...candidate sourcing, interviewing, and onboarding. Build and maintain a strong talent pipeline to meet the company's current and future staffing needs. Employee Relations Act as a point of contact for employees regarding HR policies, procedures, and programs....