Regulatory Affairs Director Jobs in Massachusetts
Regulatory Affairs Director jobs in Massachusetts concentrate heavily in life sciences, medical devices, and pharmaceutical manufacturing, making this one of the most active markets in the country for the role at every level from senior manager stepping up to first-time director through VP-level appointments. Most hiring is centered in Boston, Cambridge, and the Route 128 corridor, where established employers like Biogen, Boston Scientific, and Takeda maintain significant operations and regularly seek directors with FDA, CE marking, and combination product expertise. The most in-demand specializations are drug and biologics submissions, medical device 510(k) and PMA pathways, and global regulatory strategy. Find a role that fits below and apply directly.
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Showing 5 of 73+ Regulatory Affairs Director 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 Director Jobs in Massachusetts
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Find JobsRegulatory Affairs Director Jobs by City in Massachusetts
Where Massachusetts roles are concentrated, by current openings.
Regulatory Affairs Director 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 director jobs across Massachusetts.
- Bachelor's degree in life sciences, engineering, or a related field is required
- Minimum of eight to ten years of regulatory affairs experience in pharma or medical devices
- Direct experience managing FDA submissions including INDs, NDAs, BLAs, 510(k)s, or PMAs
- Demonstrated ability to lead cross-functional teams and manage regulatory staff
- Regulatory Affairs Certification from the Regulatory Affairs Professionals Society preferred
- Familiarity with Massachusetts-based contract manufacturers and the regional CRO ecosystem preferred
Regulatory Affairs Director Jobs in Massachusetts: Frequently Asked Questions
How do you become a regulatory affairs director in Massachusetts?
Most regulatory affairs directors in Massachusetts move into the role after accumulating deep submission experience in pharma, biotech, or medical devices, typically starting as a regulatory affairs specialist or manager. Massachusetts does not require a state-issued license for this role. The Regulatory Affairs Professionals Society offers the RAC credential, which is widely respected by Massachusetts employers and can differentiate candidates. A science or engineering degree is the standard foundation, and many employers along the Route 128 corridor and in Cambridge prefer candidates with therapeutic area depth.
How much do regulatory affairs directors make in Massachusetts?
Regulatory affairs directors 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 directors in Massachusetts?
Employers hiring regulatory affairs directors 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 large biotech headquarters and global pharma affiliates means director-level regulatory roles open year-round rather than only during product launch cycles.
Which Massachusetts cities have the most regulatory affairs director jobs?
The cities with the most regulatory affairs director openings in Massachusetts are Boston, Cambridge, and Bedford. Boston and Cambridge dominate because they anchor the largest biotech and pharmaceutical cluster in the country, while suburban Route 128 corridor locations like Waltham and Lexington host numerous regional headquarters and large device manufacturers that consistently require senior regulatory leadership.
Are there remote regulatory affairs director jobs in Massachusetts?
Yes, and more than most fields. About 86% of regulatory affairs director openings tied to Massachusetts are remote or hybrid as of November 2026, reflecting the desk-based and documentation-heavy nature of the role. Strategic regulatory work, submissions management, and agency correspondence tend to be the most remote-compatible responsibilities, while roles tied to manufacturing site compliance or lab-stage development programs are more likely to require on-site presence.
How can I get hired as a regulatory affairs director in Massachusetts with little or no experience?
The most realistic entry path is moving laterally from a regulatory affairs specialist or associate director role within a Massachusetts biotech or medical device company, building a submission portfolio before targeting director titles. Large Massachusetts employers like Biogen and Boston Scientific run structured development programs and often promote from within. Earning the RAC credential signals readiness for director-level responsibility. Regulatory affairs roles at contract research organizations in the Greater Boston area are also strong stepping stones because they provide broad submission exposure across multiple clients and therapeutic areas.
Where can I find and apply to regulatory affairs director jobs in Massachusetts?
You can find and apply to regulatory affairs director jobs in Massachusetts on Migrate Mate, which lists current Massachusetts openings. Find the roles that fit your experience and apply directly to the ones that match.
See All 73 Regulatory Affairs Director Jobs in Massachusetts
Find roles in Massachusetts that match your experience and apply in just a few clicks.
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