Regulatory Affairs Analyst Jobs in Massachusetts
Regulatory affairs analyst jobs in Massachusetts sit in one of the most active hiring markets in the country, concentrated in life sciences, pharmaceuticals, and medical devices across Greater Boston, Cambridge, and the Route 128 corridor. Major employers with lasting Massachusetts footprints include Biogen, Boston Scientific, and Takeda, each running dedicated regulatory functions across multiple product lines. Demand is strongest in FDA submissions, clinical trial compliance, and combination product regulation, with openings at everything from entry associate to senior director level. 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 Analyst jobs
Director of Quality & Regulatory Affairs
We won't show you this job again
New 8h ago
Myomo, Inc
Director of Quality & Regulatory Affairs
Burlington, Massachusetts
New 8h ago
Specialist, Regulatory Affairs
We won't show you this job again
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
We won't show you this job again
Added 4d ago
Helen of Troy
Manager, Regulatory Affairs, Home & Outdoor
Marlborough, Massachusetts
Added 4d 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 8h 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 8h 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 Analyst Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Analyst Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Cambridge
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 Analyst 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 analyst jobs across Massachusetts.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related scientific field
- Experience preparing FDA submissions including 510(k), PMA, NDA, or BLA packages
- Familiarity with CFR Title 21 regulations and ICH quality guidelines
- Proficiency with electronic submissions and document management systems such as Veeva
- Strong written communication skills for authoring regulatory documents and correspondence
- RAC certification from the Regulatory Affairs Professionals Society preferred by many Massachusetts employers
Regulatory Affairs Analyst Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs analyst in Massachusetts?
Start with a bachelor's degree in a life sciences, pharmacy, engineering, or chemistry field, which is the baseline most Massachusetts employers require. Massachusetts does not issue a state license specific to regulatory affairs, so credentialing centers on industry certification: the Regulatory Affairs Professionals Society offers the RAC credential, which many Boston-area and Route 128 employers list as preferred. Building experience through quality assurance, clinical operations, or laboratory roles at a Massachusetts biotech or medical device company is the most common entry path.
Which companies hire regulatory affairs analysts in Massachusetts?
Massachusetts regulatory affairs analyst roles are posted by Northeastern University, Katalyst Healthcares & Life Sciences, and ARTBIO and others right now, based on current listings on Migrate Mate as of November 2026. Massachusetts's dense concentration of pharmaceutical headquarters, contract research organizations, and medical device firms means openings appear across a wide range of company sizes, from global biopharmaceuticals to early-stage Cambridge startups.
Which Massachusetts cities have the most regulatory affairs analyst jobs?
Boston, Cambridge, and Bedford account for the greatest share of regulatory affairs analyst openings in Massachusetts. Greater Boston and Cambridge anchor the market because of the Kendall Square biotech cluster and major pharmaceutical headquarters, while suburban Route 128 cities like Waltham and Lexington draw strong demand from the medical device and diagnostics companies based along that corridor.
Are there remote regulatory affairs analyst jobs in Massachusetts?
Yes, and more than most fields, because the work centers on document review, submission writing, and cross-functional communication that translates well to remote settings. About 86% of regulatory affairs analyst openings tied to Massachusetts are remote or hybrid as of November 2026, reflecting the document-heavy nature of the role. Submission writing, regulatory intelligence, and labeling review are the functions most frequently offered on a fully remote basis.
How can I get hired as a regulatory affairs analyst in Massachusetts with little or no experience?
The most realistic entry path is moving laterally from a quality assurance, clinical data, or laboratory role at a Massachusetts life sciences company, where you already understand regulatory frameworks. Large Massachusetts employers including Biogen and Boston Scientific hire regulatory associates and post-doctoral fellows into structured programs that build submission experience from the ground up. Earning the RAC foundation certificate while in an adjacent role signals commitment and gives candidates a concrete edge when applying to associate-level openings in the Boston and Cambridge market.
Where can I find and apply to regulatory affairs analyst jobs in Massachusetts?
You can find and apply to regulatory affairs analyst jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across life sciences, pharmaceuticals, and medical devices. Find the roles that fit your background and apply directly through the listings.
See All 73 Regulatory Affairs Analyst Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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