Regulatory Affairs Manager Jobs in Massachusetts
Regulatory Affairs Manager jobs in Massachusetts are among the most active in the country, concentrated in the life sciences, medical device, and pharmaceutical sectors that anchor the state's economy from entry-level specialist roles through senior director positions. Boston, Cambridge, and the Route 128 corridor are the primary hiring centers, where established employers such as Biogen, Boston Scientific, and Takeda maintain large regulatory affairs teams. The most in-demand specialties are FDA submissions, drug approval pathways, and medical device compliance under 21 CFR Part 820. Find a role that fits below and apply directly.
Find JobsOverview
Open roles73
Top employerNortheastern University
Top cityBoston, MA
Cities hiring16
Work type53% Hybrid
Top industryScience
Showing 5 of 73+ Regulatory Affairs Manager jobs
Director of Quality & Regulatory Affairs
We won't show you this job again
New 7h ago
Myomo, Inc
Director of Quality & Regulatory Affairs
Burlington, Massachusetts
New 7h ago
Specialist, Regulatory Affairs
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Added 3d ago
Transmedics
Specialist, Regulatory Affairs
Andover, Massachusetts
Added 3d ago
Senior Director, Regulatory Affairs
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Added 3d ago
Repertoire Immune Medicines
Senior Director, Regulatory Affairs
Watertown, Massachusetts
Added 3d ago
Manager, Regulatory Affairs, Home & Outdoor
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Added 3d ago
Helen of Troy
Manager, Regulatory Affairs, Home & Outdoor
Marlborough, Massachusetts
Added 3d ago
Director, Regulatory Affairs - Biologics
We won't show you this job again
Added 4d ago
Vericel Corporation
Director, Regulatory Affairs - Biologics
Burlington, Massachusetts
Added 4d ago
New 7h ago
Director of Quality & Regulatory Affairs
Myomo, Inc·Burlington, Massachusetts
Job functions:
$170k - $180k/yr
Bachelor's degree
201-500 employees
Job Description
Description
Why should you join our success story?
Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient’s own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S.
What we’re looking for:
The Director of Quality and Regulatory Affairs leads the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy. This role ensures compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle. The Director partners cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes.
How You'll Drive Impact:
QA/RA Strategic Alignment & Operational Leadership
- In collaboration with senior leadership, contribute to the development and lead execution of the Quality strategy aligned with the Company size, development stage and business needs.
- Lead departmental planning and budgeting, optimizing resources and operational efficiency.
- Direct QA/RA staff, including organizational design, talent development and performance management.
- Develop and continuously improve quality programs, policies, and processes to support product performance and customer satisfaction.
- Ensure Quality Management System (QMS) processes are established, implemented, and maintained with a focus on compliance, effectiveness and scalability.
Regulatory Strategy & Compliance
- Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities, including the FDA and notified bodies.
- Act as management representative and/or person responsible for regulatory compliance.
- Oversee development and execution of global regulatory strategies for product submissions and lifecycle management (e.g., CE Mark, technical documentation).
- Monitor evolving global regulatory requirements and assess impact on the organization, adjusting plans as needed.
- Ensure compliance with FDA QMSR (Part 820), ISO 13485, EU MDR, and other applicable global regulations and standards.
- Review advertising and promotional marketing materials for regulatory compliance.
- Maintain global product regulations and change notifications.
Quality Systems
- Own and maintain the effectiveness of the Quality Management System (QMS).
- Ensure robust and compliant processes for CAPA, complaint handling, document control, risk management and supplier quality.
- Lead management review processes and quality metrics reporting, driving continuous improvement across the organization.
- Ensure ongoing inspection readiness and manage external audits (FDA, ISO, notified bodies).
Organizational Leadership & Cross-Functional Collaboration
- Partner cross-functionally to ensure alignment of quality and regulatory requirements across product development, manufacturing, clinical and commercial activities, including oversight of Design Controls, validation, and supplier quality.
- Present updates to senior leadership and, as needed, the Board of Directors on Quality and Regulatory performance, risks, and compliance status.
- Report on QMS effectiveness and identify opportunities for continuous improvement.
- Promote awareness of quality and regulatory requirements across the organization.
- Ensure activities are conducted in compliance with applicable regulations, company policies, and ethical standards.
Post-Market & Risk Management
- Oversee post-market surveillance activities, including complaint handling, MDR/Vigilance reporting, and trend analysis.
- Ensure effective risk management processes in alignment with ISO 14971.
- Lead cross-functional investigations, root cause analysis, and corrective/preventive action
Management
- Lead and develop the QA/RA team, including hiring, performance management, and coaching.
- Define roles, responsibilities, and performance expectations aligned with business objectives.
- Ensure effective resource planning and prioritization to meet project and compliance needs.
- Build and evolve team capabilities to support organizational growth and regulatory requirements.
What You'll Bring:
- Bachelor’s degree in a scientific, technical, or related discipline; advanced degree preferred.
- 8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience.
- 5+ years of experience with Class I and/or Class II medical devices.
- Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions.
- Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls.
- Experience managing Quality Management Systems (QMS) for medical devices (Ketryx preferred)
- Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred).
- Demonstrated experience leading QA/RA teams, including talent development and performance management.
- RAC certification or equivalent is preferred.
- Experience operating in a high-growth or scaling organization.
- Strong communication (verbal and written), stakeholder management and cross-functional collaboration skills.
About Myomo, Inc
Our mission to enable independence and confidence for stroke survivors as well as those living with MS, BPI, and other neurological disorders. Together we continue to break through barriers, defining the limits of possibility both in medical device robotics and our global system of care.
Myomo, Inc
Director of Quality & Regulatory Affairs
Burlington, Massachusetts
New 7h ago201-500 employees
Job functions:
$170k - $180k/yr
Bachelor's degree
Job Description
Description
Why should you join our success story?
Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro® product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient’s own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S.
What we’re looking for:
The Director of Quality and Regulatory Affairs leads the global QA/RA function and is responsible for execution of the company’s quality and regulatory strategy. This role ensures compliance with applicable global regulations and standards (including FDA and ISO requirements) and oversees quality systems across the product lifecycle. The Director partners cross-functionally to support product development, regulatory submissions, and ongoing compliance activities, while driving continuous improvement in quality processes.
How You'll Drive Impact:
QA/RA Strategic Alignment & Operational Leadership
- In collaboration with senior leadership, contribute to the development and lead execution of the Quality strategy aligned with the Company size, development stage and business needs.
- Lead departmental planning and budgeting, optimizing resources and operational efficiency.
- Direct QA/RA staff, including organizational design, talent development and performance management.
- Develop and continuously improve quality programs, policies, and processes to support product performance and customer satisfaction.
- Ensure Quality Management System (QMS) processes are established, implemented, and maintained with a focus on compliance, effectiveness and scalability.
Regulatory Strategy & Compliance
- Lead regulatory activities and compliance interactions, serving as the primary liaison with regulatory authorities, including the FDA and notified bodies.
- Act as management representative and/or person responsible for regulatory compliance.
- Oversee development and execution of global regulatory strategies for product submissions and lifecycle management (e.g., CE Mark, technical documentation).
- Monitor evolving global regulatory requirements and assess impact on the organization, adjusting plans as needed.
- Ensure compliance with FDA QMSR (Part 820), ISO 13485, EU MDR, and other applicable global regulations and standards.
- Review advertising and promotional marketing materials for regulatory compliance.
- Maintain global product regulations and change notifications.
Quality Systems
- Own and maintain the effectiveness of the Quality Management System (QMS).
- Ensure robust and compliant processes for CAPA, complaint handling, document control, risk management and supplier quality.
- Lead management review processes and quality metrics reporting, driving continuous improvement across the organization.
- Ensure ongoing inspection readiness and manage external audits (FDA, ISO, notified bodies).
Organizational Leadership & Cross-Functional Collaboration
- Partner cross-functionally to ensure alignment of quality and regulatory requirements across product development, manufacturing, clinical and commercial activities, including oversight of Design Controls, validation, and supplier quality.
- Present updates to senior leadership and, as needed, the Board of Directors on Quality and Regulatory performance, risks, and compliance status.
- Report on QMS effectiveness and identify opportunities for continuous improvement.
- Promote awareness of quality and regulatory requirements across the organization.
- Ensure activities are conducted in compliance with applicable regulations, company policies, and ethical standards.
Post-Market & Risk Management
- Oversee post-market surveillance activities, including complaint handling, MDR/Vigilance reporting, and trend analysis.
- Ensure effective risk management processes in alignment with ISO 14971.
- Lead cross-functional investigations, root cause analysis, and corrective/preventive action
Management
- Lead and develop the QA/RA team, including hiring, performance management, and coaching.
- Define roles, responsibilities, and performance expectations aligned with business objectives.
- Ensure effective resource planning and prioritization to meet project and compliance needs.
- Build and evolve team capabilities to support organizational growth and regulatory requirements.
What You'll Bring:
- Bachelor’s degree in a scientific, technical, or related discipline; advanced degree preferred.
- 8-10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device industry, including significant management experience.
- 5+ years of experience with Class I and/or Class II medical devices.
- Experience operating within FDA-regulated cGMP environments, including regulatory submissions and agency interactions.
- Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, EU MDR, ISO 14971, and Design Controls.
- Experience managing Quality Management Systems (QMS) for medical devices (Ketryx preferred)
- Experience supporting global regulatory activities (e.g., EU, Canada, APAC preferred).
- Demonstrated experience leading QA/RA teams, including talent development and performance management.
- RAC certification or equivalent is preferred.
- Experience operating in a high-growth or scaling organization.
- Strong communication (verbal and written), stakeholder management and cross-functional collaboration skills.
About Myomo, Inc
Our mission to enable independence and confidence for stroke survivors as well as those living with MS, BPI, and other neurological disorders. Together we continue to break through barriers, defining the limits of possibility both in medical device robotics and our global system of care.
See All 73 Regulatory Affairs Manager Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Manager Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Boston
30 jobsCambridge
13 jobsBedford
5 jobsSomerville
5 jobsWatertown
4 jobsWaltham
3 jobsBurlington
3 jobsCanton
1 jobWoburn
1 jobAndover
1 jobNeedham
1 jobRaynham
1 jobMarlboro
1 jobTempleton
1 jobMarlborough
1 jobSouth Boston
1 jobRegulatory Affairs Manager Job Market in Massachusetts
A snapshot from current Massachusetts openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Science & Research
- Biotechnology & Pharmaceuticals
- Consulting & Professional Services
- Medical Devices
- Healthcare & Medical Services
What Massachusetts Employers Look For
The qualifications that appear most often in regulatory affairs manager jobs across Massachusetts.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field required
- Direct experience with FDA regulatory submissions including INDs, NDAs, or 510(k)s
- Familiarity with 21 CFR regulations and ICH guidelines for pharmaceutical or device products
- RAC certification from the Regulatory Affairs Professionals Society strongly preferred
- Experience managing cross-functional teams through regulatory review and approval cycles
- Strong technical writing skills for preparing regulatory documents and agency correspondence
Regulatory Affairs Manager Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs manager in Massachusetts?
Most regulatory affairs managers in Massachusetts start with a bachelor's degree in a life science, engineering, or pharmacy discipline, then build several years of experience in a regulated industry such as biotech, pharma, or medical devices. Massachusetts does not require a state-issued license specific to regulatory affairs, but the RAC credential from the Regulatory Affairs Professionals Society is widely expected by Massachusetts employers and strengthens candidacy at every level.
How much do regulatory affairs managers make in Massachusetts?
Regulatory affairs managers in Massachusetts earn a median of about $102,060 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $63,340 for the lowest 10% to over $161,920 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs managers in Massachusetts?
Employers hiring regulatory affairs managers in Massachusetts right now include Northeastern University, Katalyst Healthcares & Life Sciences, and ARTBIO, based on current listings on Migrate Mate as of November 2026. Massachusetts's dense concentration of biotech and medical device headquarters along Route 128 and in the Kendall Square area means hiring activity in this role remains consistent throughout the year.
Which Massachusetts cities have the most regulatory affairs manager jobs?
Boston, Cambridge, and Bedford have the most regulatory affairs manager openings in Massachusetts. Boston and Cambridge dominate because of the Kendall Square biotech cluster and major pharmaceutical headquarters, while suburban Route 128 corridor cities draw significant hiring from medical device and specialty pharma companies anchored there.
Are there remote regulatory affairs manager jobs in Massachusetts?
Yes, and more than most fields. About 86% of regulatory affairs manager openings tied to Massachusetts are remote or hybrid as of November 2026, reflecting the document-heavy and analytical nature of much of the work. Submission writing, labeling review, and regulatory intelligence roles are the most consistently offered in remote or hybrid arrangements, while positions requiring hands-on lab or manufacturing site oversight tend to be fully on-site.
How can I get hired as a regulatory affairs manager in Massachusetts with little or no experience?
The most realistic entry path is a regulatory affairs associate or coordinator role at a Massachusetts biotech or medical device company, where you support submissions and document management before moving into a management track. Large Massachusetts employers in the Cambridge and Waltham corridors regularly bring on candidates from adjacent roles such as quality assurance, clinical operations, or scientific writing. Earning the RAC credential or completing a graduate certificate in regulatory science gives candidates a clear edge when competing for first roles.
Where can I find and apply to regulatory affairs manager jobs in Massachusetts?
You can find and apply to regulatory affairs manager jobs in Massachusetts on Migrate Mate, which lists current openings across the state. Find roles that fit your background and apply directly to the ones that match.
See All 73 Regulatory Affairs Manager Jobs in Massachusetts
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