Lead Quality and Regulatory Manager

StemWave; Boston (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

StemWave, a pioneering medical device startup, seeks a Lead Quality and Regulatory Manager to oversee compliance and quality strategy during a pivotal growth phase. This role requires strong experience in medical device quality systems and offers an opportunity to impact the company's transformation significantly.

Benefits

Competitive compensation structure

Premium medical benefits

Ample room for growth

Qualifications

• 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.

Responsibilities

• Own and manage the Quality Management System (QMS) ensuring compliance with ISO 13485.
• Prepare for and lead internal, customer, and third-party audits.
• Manage CAPA, nonconformance, and complaint systems from initiation through closure.

Skills

Project Management

Communication

Organizational Skills

Detail-Oriented

Continuous Improvement

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

eQMS systems

Job description

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Job Title: Lead Quality and Regulatory Manager

Location: 18 Tower Office Park, Woburn, MA

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

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