StemWave
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Job Title:
Lead Quality and Regulatory Manager Location:
18 Tower Office Park, Woburn, MA Department:
Quality Management Reports To:
CTO Employment Type:
Full-Time Company Description StemWave is a fast-growing medical device startup in Massachusetts, pioneering orthopedic shockwave technology in the U.S. Ranked among the fastest-growing privately held companies in 2023 and 2024, we are expanding our team and capabilities. Learn more: www.stemwave.com Position Summary StemWave is evolving from distributor to manufacturer and doubling its distribution center size this September. This is a rare opportunity to lead Quality and Regulatory management at a pivotal moment—owning compliance processes, driving quality strategy, and shaping our growth. Specifically, the Lead Quality and Regulatory Manager will be responsible for overseeing the ongoing maintenance, enhancement, and compliance of StemWave’s Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards. This role will lead audits, manage CAPAs, and drive quality integration throughout the organization. If you’re ready to take charge and make a real impact during this transformation, this role is for you. Key Responsibilities Own and manage the Quality Management System (QMS) ensuring compliance with ISO 13485, FDA QSR, and international regulatory standards Prepare for and lead internal, customer, and third-party audits (FDA, notified bodies) Oversee document control and ensure timely creation, review, approval, and training of SOPs, work instructions, and quality records Manage CAPA, nonconformance, and complaint systems from initiation through closure, including investigations and root cause analysis Lead risk management activities, including FMEAs and risk files, in compliance with ISO 14971 Support design control and product development teams to align documentation with QMS requirements Drive continuous improvement projects within QMS and quality operations Train staff on QMS processes and best practices Collaborate cross-functionally with Manufacturing, Engineering, Regulatory, and Customer Service teams Lead MDSAP audit process as primary compliance strategy; CE marking is interim until MDSAP certification is obtained Qualifications Required: Bachelor’s degree in Engineering, Life Sciences, or related field 5+ years’ experience in medical device quality systems Strong knowledge of ISO 13485, 21 CFR Part 820, and global regulations Experience leading audits and managing CAPA, NCR, and complaint programs Strong project management, communication, and organizational skills Detail-oriented and focused on continuous improvement Preferred: Experience with eQMS systems (e.g., Greenlight Guru, MasterControl, Veeva) Familiarity with EU MDR, MDSAP, and international submissions Lead Auditor certification or formal audit training Experience supporting manufacturing transfer or scale-up We offer a competitive compensation structure, premium medical benefits, ample room for growth and the ability to develop your hard and soft skills. At StemWave, we're not just building devices—we're building a movement. Join us and be a key contributor to our growth and success. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Device Referrals increase your chances of interviewing at StemWave by 2x Get notified about new Quality Regulatory Manager jobs in
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Lead Quality and Regulatory Manager Location:
18 Tower Office Park, Woburn, MA Department:
Quality Management Reports To:
CTO Employment Type:
Full-Time Company Description StemWave is a fast-growing medical device startup in Massachusetts, pioneering orthopedic shockwave technology in the U.S. Ranked among the fastest-growing privately held companies in 2023 and 2024, we are expanding our team and capabilities. Learn more: www.stemwave.com Position Summary StemWave is evolving from distributor to manufacturer and doubling its distribution center size this September. This is a rare opportunity to lead Quality and Regulatory management at a pivotal moment—owning compliance processes, driving quality strategy, and shaping our growth. Specifically, the Lead Quality and Regulatory Manager will be responsible for overseeing the ongoing maintenance, enhancement, and compliance of StemWave’s Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant standards. This role will lead audits, manage CAPAs, and drive quality integration throughout the organization. If you’re ready to take charge and make a real impact during this transformation, this role is for you. Key Responsibilities Own and manage the Quality Management System (QMS) ensuring compliance with ISO 13485, FDA QSR, and international regulatory standards Prepare for and lead internal, customer, and third-party audits (FDA, notified bodies) Oversee document control and ensure timely creation, review, approval, and training of SOPs, work instructions, and quality records Manage CAPA, nonconformance, and complaint systems from initiation through closure, including investigations and root cause analysis Lead risk management activities, including FMEAs and risk files, in compliance with ISO 14971 Support design control and product development teams to align documentation with QMS requirements Drive continuous improvement projects within QMS and quality operations Train staff on QMS processes and best practices Collaborate cross-functionally with Manufacturing, Engineering, Regulatory, and Customer Service teams Lead MDSAP audit process as primary compliance strategy; CE marking is interim until MDSAP certification is obtained Qualifications Required: Bachelor’s degree in Engineering, Life Sciences, or related field 5+ years’ experience in medical device quality systems Strong knowledge of ISO 13485, 21 CFR Part 820, and global regulations Experience leading audits and managing CAPA, NCR, and complaint programs Strong project management, communication, and organizational skills Detail-oriented and focused on continuous improvement Preferred: Experience with eQMS systems (e.g., Greenlight Guru, MasterControl, Veeva) Familiarity with EU MDR, MDSAP, and international submissions Lead Auditor certification or formal audit training Experience supporting manufacturing transfer or scale-up We offer a competitive compensation structure, premium medical benefits, ample room for growth and the ability to develop your hard and soft skills. At StemWave, we're not just building devices—we're building a movement. Join us and be a key contributor to our growth and success. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Device Referrals increase your chances of interviewing at StemWave by 2x Get notified about new Quality Regulatory Manager jobs in
Boston, MA . Manager, Quality Assurance (QA), Global QMS
Canton, MA $70,000.00-$90,000.00 3 days ago Marlborough, MA $127,900.00-$243,000.00 6 days ago Senior Manager, R&D Quality Assurance (Hybrid)
Lowell, MA $105,000.00-$125,000.00 3 weeks ago Manager, External and Regulatory Affairs
Quality Assurance and Facilities Manager
Food Safety & Quality Assurance Manager (Relocation Available)
Sr. Manager, Global Regulatory Publishing
Manager - Quality Assurance & Food Safety
Senior Manager Manufacturing (CMC) Quality Assurance
Quality Assurance Specialist/Manager – Bioanalytical Laboratory
Mansfield, MA $115,900.00-$173,800.00 1 week ago Sr. Regulatory Affairs Specialist (Austin, TX)
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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