Regulatory Affairs Jobs in Massachusetts
Regulatory affairs jobs in Massachusetts are among the most active in the country, concentrated in the state's world-leading life sciences, biotechnology, and medical device sectors, with openings at every level from entry-level specialist to senior director. Boston, Cambridge, and the Route 128 corridor are the primary hiring hubs, home to major employers such as Pfizer, Takeda, and Boston Scientific, which maintain substantial regulatory functions in the state. FDA submissions, pharmaceutical quality compliance, and medical device regulatory strategy are the most in-demand specializations. Find a role that fits below and apply directly.
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Showing 5 of 73+ Regulatory Affairs jobs
Description
Why should you join our success story?
How You'll Drive Impact:
- 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.
- 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.
- 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).
- 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.
- 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
- 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
Description
Why should you join our success story?
How You'll Drive Impact:
- 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.
- 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.
- 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).
- 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.
- 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
- 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
See All 73 Regulatory Affairs Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
Find Regulatory Affairs JobsRegulatory Affairs Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs 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 jobs across Massachusetts.
- Bachelor's degree in life sciences, pharmacy, or a related scientific discipline required
- Working knowledge of FDA regulations including 21 CFR and ICH guidelines
- Experience preparing and submitting INDs, NDAs, 510(k)s, or PMAs preferred
- Familiarity with Massachusetts-based biotech or medical device regulatory environments
- Strong technical writing skills for regulatory submissions and internal documentation
- RAC certification from the Regulatory Affairs Professionals Society considered an advantage
Regulatory Affairs Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs specialist in Massachusetts?
Most regulatory affairs roles in Massachusetts require at minimum a bachelor's degree in a life sciences field such as biology, chemistry, or pharmacy, though many employers prefer a master's degree. No state-issued license is required to practice regulatory affairs in Massachusetts. Candidates typically build credentials through industry experience, internships at local biotech or medical device companies, and the Regulatory Affairs Professionals Society certification, which Massachusetts employers widely recognize as a professional benchmark.
How much do regulatory affairses make in Massachusetts?
Regulatory affairses 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 specialists in Massachusetts?
Employers hiring regulatory affairs specialists 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 pharmaceutical and medical device headquarters along the Route 128 corridor means a large share of openings come from companies with established, multi-team regulatory departments rather than early-stage startups.
Which Massachusetts cities have the most regulatory affairs jobs?
The cities with the most regulatory affairs openings in Massachusetts are Boston, Cambridge, and Bedford. The distribution reflects the life sciences cluster anchored in Boston and Cambridge, where major biotech and pharmaceutical companies maintain regulatory functions, while suburban Route 128 corridor locations such as Waltham and Lexington also generate consistent demand from medical device and specialty pharma employers.
Are there remote regulatory affairs jobs in Massachusetts?
Yes, and more than most fields. Regulatory affairs work is largely document-driven and desk-based, making it well suited to remote and hybrid arrangements. About 86% of regulatory affairs openings tied to Massachusetts are remote or hybrid as of November 2026, reflecting broader industry flexibility in this function. Roles focused on regulatory writing, submissions management, and intelligence tend to carry the highest remote availability, while positions requiring frequent lab or manufacturing site interaction are more likely to require on-site presence.
How can I get hired as a regulatory affairs specialist in Massachusetts with little or no experience?
The most realistic entry path is through a regulatory affairs internship or co-op at one of the many Boston-area or Route 128 biotech and pharmaceutical companies that run formal early-career programs, including larger employers with structured associate or junior specialist roles. Adjacent positions such as quality assurance associate, clinical data coordinator, or regulatory document specialist are common lateral entry points. A life sciences degree combined with RAC exam preparation and any submission or documentation coursework strengthens a candidate's profile considerably with Massachusetts employers.
Where can I find and apply to regulatory affairs jobs in Massachusetts?
You can find and apply to regulatory affairs jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across the life sciences, biotech, pharmaceutical, and medical device sectors. Find roles that match your experience and specialization and apply directly from the listings.
See All 73 Regulatory Affairs Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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