Regulatory Affairs Associate Jobs in Massachusetts
Regulatory affairs associate jobs in Massachusetts are among the most active in the country, concentrated in the state's dense biopharma, medical device, and life sciences sectors, with openings at every level from entry-level coordinators through senior associates. Boston, Cambridge, and the Route 128 corridor anchor most of the hiring, where established employers like Johnson & Johnson, Hologic, and Takeda maintain significant regulatory operations. FDA submissions, combination products, and post-market surveillance are the most in-demand specialties driving current openings. Find a role that fits below and apply directly.
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Showing 5 of 73+ Regulatory Affairs Associate 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 Associate Jobs in Massachusetts
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Find JobsRegulatory Affairs Associate Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Associate 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 associate jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, pharmacy, or a closely related field
- Familiarity with FDA regulations including 21 CFR Parts 820, 803, and 314
- Experience preparing regulatory submissions such as 510(k), PMA, or NDA packages
- Working knowledge of quality management systems and document control processes
- Strong technical writing skills for regulatory correspondence and submission content
- Proficiency with electronic submission tools such as eCTD publishing platforms
Regulatory Affairs Associate Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs associate in Massachusetts?
Most regulatory affairs associate roles in Massachusetts require a bachelor's degree in a life sciences, engineering, or pharmacy discipline, though some employers accept other technical fields with relevant coursework. While no Massachusetts state license is required for the role itself, many employers prefer or require candidates to hold or pursue the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society, which is widely recognized across the state's biopharma and medical device industries.
How much do regulatory affairs associates make in Massachusetts?
Regulatory affairs associates 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 associates in Massachusetts?
Employers hiring regulatory affairs associates 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 concentration of global biopharma headquarters and medical device firms along the Route 128 corridor means regulatory teams here often support both domestic FDA filings and international market access work.
Which Massachusetts cities have the most regulatory affairs associate jobs?
The cities with the most regulatory affairs associate openings in Massachusetts are Boston, Cambridge, and Bedford. The concentration reflects the state's life sciences footprint, with Greater Boston and Cambridge home to major biopharma headquarters and research campuses, while suburban Route 128 corridor communities host large medical device and combination product manufacturers that maintain dedicated regulatory affairs departments.
Are there remote regulatory affairs associate jobs in Massachusetts?
Yes, and more than many technical roles, since regulatory affairs work is largely documentation, submission preparation, and cross-functional coordination that translates well to remote settings. About 86% of regulatory affairs associate openings tied to Massachusetts are remote or hybrid as of November 2026, reflecting the desk-based nature of the work. Submission writing, regulatory intelligence, and labeling review tend to be the functions most commonly performed fully remotely.
How can I get hired as a regulatory affairs associate in Massachusetts with little or no experience?
The most realistic entry path is applying to regulatory affairs coordinator or quality assurance associate roles at Massachusetts-based medical device or biopharma companies, which often serve as direct feeders into regulatory associate positions. Large employers across the Route 128 corridor and Greater Boston regularly hire new graduates for these junior roles. Completing a Regulatory Affairs Certification coursework track or gaining internship experience through programs at Massachusetts life sciences companies strengthens a candidate's profile significantly. Adjacent roles in quality, clinical operations, or scientific writing also provide a recognized bridge into regulatory affairs.
Where can I find and apply to regulatory affairs associate jobs in Massachusetts?
You can find and apply to regulatory affairs associate jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings across the biopharma, medical device, and life sciences sectors. Find roles that fit your background and apply directly to the employers posting them.
See All 73 Regulatory Affairs Associate Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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