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 roles76
Top employerMerck KGaA
Top cityBoston, MA
Cities hiring24
Work type41% Hybrid
Top industryBiotechnology
Showing 5 of 76+ Regulatory Affairs Analyst jobs
Regulatory Affairs Spec
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New 19h ago
Dräger
Regulatory Affairs Spec
Andover, Massachusetts
New 19h ago
Regulatory Affairs Specialist II – Global Markets
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Added 1d ago
TSK Laboratory
Regulatory Affairs Specialist II – Global Markets
Boston, Massachusetts
Added 1d ago
Director, Regulatory Affairs CMC
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Added 3d ago
Sionna Therapeutics
Director, Regulatory Affairs CMC
Waltham, Massachusetts
Added 3d ago
Senior Specialist, Regulatory Affairs
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Added 1w ago
Zoll Medical Corporation
Senior Specialist, Regulatory Affairs
Massachusetts
Added 1w ago
Manager, Regulatory Affairs
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Added 1w ago
Relay Therapeutics
Manager, Regulatory Affairs
Cambridge, Massachusetts
Added 1w ago
New 19h ago
Regulatory Affairs Spec
Dräger·Andover, Massachusetts
Job functions:
$84k - $101k/yr
Hybrid
Bachelor's degree in mechanical engineering
10,000+ employees
Job Description
Business Unit: Draeger Medical Systems, Inc., Job-ID: 1284
Location: Andover
Function: Quality
Work Location: Hybrid
Employment Type: Permanent
The Job Responsibilities
The Regulatory Affairs Specialist will work hybrid in our Andover, MA office.
The Regulatory Affairs Specialist will develop the basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures. This position will work with supervision to ensure continued market assess and ongoing regulatory compliance of the Draeger Patient Monitoring device portfolio in US and international markets. This position will support the gathering of regulatory intelligence to assist in the development of local, regional, and global regulatory strategies, and will support the execution of post market product lifecycle management.
Develops regulatory strategies by;
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Assessment of options and milestones to de-risk development programs and align with current regulatory requirements and agency guidance.
- Documenting path(s) to regulatory approval in the Regulatory Affairs Plan (RAP)
- Developing clear rationales for Letter-to-File (LTF) for product changes that will not impact product approvals or clearances
Responsible for:
- The procurement, assembly, and packaging of the required deliverables for the submission of product registration and approval information as appropriate.
- Preparation and submission of regulatory documentation according to applicable regulatory requirements and guidelines
- Communication and interaction with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
- Review labeling and marketing literatures for compliance with regulatory requirements.
Responsible for providing product support in preparing US and non-US product submissions (510(k), Technical files, Canadian Licenses and International Registrations), by assessing the acceptability of quality, preclinical, and clinical documents in regulatory submissions to ensure compliance with applicable regulations.
Provide support for domestic (federal, state, and local) and International products registrations, by:
- Researching existing documentation, preparing summary information, memos or statements (including CFG’s; certifications, apostille, and consularization).
- Partnering with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
- Assess global impact of changes to launched products and support notifications/submissions as required
- Supporting product life cycle management activities.
Provide import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate.
- Review labeling and marketing literatures for compliance with regulatory requirements
- Participates in the annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals.
Maintain knowledge and application skills of regulations, standards and codes within job scope by doing the following:
- Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products
- Monitor and evaluate medical device regulation changes and develop and execute strategies for maintaining products on the global market.
Performs other duties as needed and assigned.
Your Qualifications
Education:
- BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience.
Related Experience:
- Minimum of 3-6 years of Regulatory experience in medical device industry is required. Minimum of 2 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities.
Special Competencies or Certifications:
- Regulatory Affairs Certification (RAC) a plus
- Knowledge of U.S. and International regulatory requirements for medical devices
- Proven record of supporting project teams
- Good Microsoft application skills
- Excellent written and oral communication skills
- Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820
Work Environment / Conditions:
- Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
- Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.
- Ability to travel nationally /internationally, up to 5-10% of the time
The targeted pay range for this position is typically between $84,100 - $100,900. We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job-related knowledge, skills, experience, and other objective business considerations. This position is eligible for the following additional compensation:annual bonus.
Dräger Benefits
At Draeger, Technology for Life means supporting our people in every aspect of their lives. We offer a competitive benefits package that may include:
- Medical, dental, and vision insurance
- Life, short- and long-term disability coverage
- 401(k) with company match
- Over 4 weeks of paid time off, plus holidays and parental leave
- Flexible spending accounts and employee assistance program
Select locations also offer free parking, an on-site gym, cafeteria, and game room.
Talk to your Draeger recruiter to learn more!
Who we are
We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle “Technology for Life”.
Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.
Draeger is an Equal Opportunity Employer.
Interested?
Please, apply directly through our career portal.
We look forward to receiving your application.
We look forward to receiving your application.
Dräger
Regulatory Affairs Spec
Andover, Massachusetts
New 19h ago10,000+ employees
Job functions:
$84k - $101k/yr
Hybrid
Bachelor's degree in mechanical engineering
Job Description
Business Unit: Draeger Medical Systems, Inc., Job-ID: 1284
Location: Andover
Function: Quality
Work Location: Hybrid
Employment Type: Permanent
The Job Responsibilities
The Regulatory Affairs Specialist will work hybrid in our Andover, MA office.
The Regulatory Affairs Specialist will develop the basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures. This position will work with supervision to ensure continued market assess and ongoing regulatory compliance of the Draeger Patient Monitoring device portfolio in US and international markets. This position will support the gathering of regulatory intelligence to assist in the development of local, regional, and global regulatory strategies, and will support the execution of post market product lifecycle management.
Develops regulatory strategies by;
- Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Assessment of options and milestones to de-risk development programs and align with current regulatory requirements and agency guidance.
- Documenting path(s) to regulatory approval in the Regulatory Affairs Plan (RAP)
- Developing clear rationales for Letter-to-File (LTF) for product changes that will not impact product approvals or clearances
Responsible for:
- The procurement, assembly, and packaging of the required deliverables for the submission of product registration and approval information as appropriate.
- Preparation and submission of regulatory documentation according to applicable regulatory requirements and guidelines
- Communication and interaction with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
- Review labeling and marketing literatures for compliance with regulatory requirements.
Responsible for providing product support in preparing US and non-US product submissions (510(k), Technical files, Canadian Licenses and International Registrations), by assessing the acceptability of quality, preclinical, and clinical documents in regulatory submissions to ensure compliance with applicable regulations.
Provide support for domestic (federal, state, and local) and International products registrations, by:
- Researching existing documentation, preparing summary information, memos or statements (including CFG’s; certifications, apostille, and consularization).
- Partnering with global regulatory affiliates and leverage product expertise to provide submission documentation for expedited international market access and sustaining support.
- Assess global impact of changes to launched products and support notifications/submissions as required
- Supporting product life cycle management activities.
Provide import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate.
- Review labeling and marketing literatures for compliance with regulatory requirements
- Participates in the annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals.
Maintain knowledge and application skills of regulations, standards and codes within job scope by doing the following:
- Acquire and apply a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products
- Monitor and evaluate medical device regulation changes and develop and execute strategies for maintaining products on the global market.
Performs other duties as needed and assigned.
Your Qualifications
Education:
- BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience.
Related Experience:
- Minimum of 3-6 years of Regulatory experience in medical device industry is required. Minimum of 2 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities.
Special Competencies or Certifications:
- Regulatory Affairs Certification (RAC) a plus
- Knowledge of U.S. and International regulatory requirements for medical devices
- Proven record of supporting project teams
- Good Microsoft application skills
- Excellent written and oral communication skills
- Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J-GMP and 21 CFR Part 820
Work Environment / Conditions:
- Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc.
- Ability to work in a fast-paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc.
- Ability to travel nationally /internationally, up to 5-10% of the time
The targeted pay range for this position is typically between $84,100 - $100,900. We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job-related knowledge, skills, experience, and other objective business considerations. This position is eligible for the following additional compensation:annual bonus.
Dräger Benefits
At Draeger, Technology for Life means supporting our people in every aspect of their lives. We offer a competitive benefits package that may include:
- Medical, dental, and vision insurance
- Life, short- and long-term disability coverage
- 401(k) with company match
- Over 4 weeks of paid time off, plus holidays and parental leave
- Flexible spending accounts and employee assistance program
Select locations also offer free parking, an on-site gym, cafeteria, and game room.
Talk to your Draeger recruiter to learn more!
Who we are
We’re hiring! If you want your contributions to make a real difference, check out this new career opportunity with us at Draeger where we are led by the guiding principle “Technology for Life”.
Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.
Draeger is an Equal Opportunity Employer.
Interested?
Please, apply directly through our career portal.
We look forward to receiving your application.
We look forward to receiving your application.
See All 76 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.
Waltham
8 jobsCambridge
8 jobsBillerica
5 jobsSomerville
4 jobsWoburn
3 jobsAyer
2 jobsAndover
2 jobsNeedham
2 jobsMansfield
2 jobsWatertown
2 jobsChelmsford
2 jobsLowell
1 jobNewton
1 jobBedford
1 jobBeverly
1 jobMilford
1 jobWalpole
1 jobWestford
1 jobBurlington
1 jobFramingham
1 jobWestborough
1 jobSouth Boston
1 jobNorth Billerica
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
- Biotechnology & Pharmaceuticals15
- Science & Research6
- Healthcare & Medical Services6
- Medical Devices3
- Consulting & Professional Services3
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 Merck KGaA, Takeda Pharmaceuticals, and Sanofi and others right now, based on current listings on Migrate Mate as of July 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, Waltham, and Cambridge 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 61% of regulatory affairs analyst openings tied to Massachusetts are remote or hybrid as of July 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 76 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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