Regulatory Affairs Specialist Jobs in Massachusetts
Regulatory Affairs Specialist jobs in Massachusetts are among the most active in the country, concentrated in the life sciences, biotech, and medical device sectors that anchor the state's economy at every level from entry-level coordinator through senior director. Boston, Cambridge, and the Route 128 corridor are the primary hiring centers, where established employers such as Biogen, Boston Scientific, and Thermo Fisher Scientific maintain large regulatory teams. The most consistent demand is for specialists in FDA submissions, combination products, and quality management systems. Find a role that fits below and apply directly.
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Showing 5 of 73+ Regulatory Affairs Specialist 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 Specialist Jobs in Massachusetts
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Find JobsRegulatory Affairs Specialist Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Specialist 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 specialist jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, chemistry, or a closely related field
- Experience with FDA submissions including 510(k), PMA, BLA, or NDA filings
- Familiarity with 21 CFR regulations, ICH guidelines, and GxP quality standards
- Proficiency preparing and reviewing technical documentation and regulatory dossiers
- Experience supporting audits, inspections, or interactions with FDA or other regulatory agencies
- Strong cross-functional collaboration skills working with R&D, quality, and manufacturing teams
Regulatory Affairs Specialist Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs specialist in Massachusetts?
Most regulatory affairs specialists in Massachusetts start with a bachelor's degree in a life sciences or engineering discipline, then build experience in quality assurance, clinical operations, or product development before moving into a dedicated regulatory role. Massachusetts does not require a state-issued license for this position. Many employers prefer or require the Regulatory Affairs Certification issued by the Regulatory Affairs Professionals Society, which demonstrates competency across FDA frameworks relevant to the state's dominant biotech and medical device industries.
How much do regulatory affairs specialists make in Massachusetts?
Regulatory affairs specialists 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 high concentration of FDA-regulated biotech, pharmaceutical, and medical device companies means hiring is sustained year-round rather than tied to a single industry cycle.
Which Massachusetts cities have the most regulatory affairs specialist jobs?
Boston, Cambridge, and Bedford have the most regulatory affairs specialist openings in Massachusetts. Boston and Cambridge lead because of the dense cluster of biotech headquarters, academic medical centers, and established pharmaceutical firms along the Kendall Square corridor and in the Seaport district, while suburban Route 128 communities like Waltham, Lexington, and Marlborough contribute significantly due to the large medical device and life sciences campuses based there.
Are there remote regulatory affairs specialist jobs in Massachusetts?
Yes, and more than many specialized roles, because much of the work involves reviewing documents, preparing submissions, and coordinating with cross-functional teams rather than hands-on laboratory or manufacturing tasks. About 86% of regulatory affairs specialist openings tied to Massachusetts are remote or hybrid as of November 2026. Submission writing, labeling review, and regulatory strategy roles tend to be the most consistently remote, while positions tied to ongoing site inspections or manufacturing oversight 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 quality assurance associate, clinical research coordinator, or regulatory affairs coordinator role at a Massachusetts biotech or medical device company, which builds direct familiarity with FDA-regulated environments. Large employers such as Biogen and Boston Scientific hire into rotational programs and associate-level regulatory roles designed for candidates with limited experience. Pursuing the Regulatory Affairs Certification candidate track while in an adjacent role and building hands-on experience with documentation systems gives candidates a concrete edge in a competitive market.
Where can I find and apply to regulatory affairs specialist jobs in Massachusetts?
You can find and apply to regulatory affairs specialist jobs in Massachusetts on Migrate Mate, which lists current openings from employers across the state. Find roles that fit your experience level and target location, then apply directly to the ones that match.
See All 73 Regulatory Affairs Specialist Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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