280 Results for

Regulatory Specialist Jobs in Massachusetts

Jobs

Westford, Massachusetts17 days ago

$90,000–$100,000 Per Year

The Contracts & Compliance Specialist manages the full lifecycle of government and commercial contracts, ensuring compliance with applicable regulations, including FAR, DFARS, and export control laws. This role is essential to mitigating risk and maintaining contractual integrity within a highly regulated government environment.

New!

Andover, MA1 day ago

$60,000–$65,000

Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.

New!

Framingham, MA1 day ago

$80,000–$90,000

New!

Boston, MA1 day ago

$35–$40

New!

North Andover, MA1 day ago

$47,840–$49,920

New!

Worcester, MA4 days ago

Where relevant, oversee or collaborate with specialty sections such as Pediatric & Adolescent Gynecology, Complex Family Planning, and Complex Benign Gynecology/Minimally Invasive Gynecologic Surgery, and other subspecialty divisions including Maternal-Fetal Medicine, Gynecologic Oncology, Reproductive Endocrinology and Infertility, and Urogynecology. The largest division in the Department, including academic specialists in general obstetrics and gynecology, family planning specialists, complex benign gynecology/minimally invasive gynecologic surgery specialists, pediatric and adolescent gynecology specialists, and advanced practice clinicians.

New!

Springfield, MAToday

Provides a smooth coordination of care of patients to home care by overseeing patient education, care planning, and coordination with multiple providers, case managers and other clinical needs within established payer and financial guidelines. Performs all clinical aspects of the intake process, including communication with patients and families and admitting clinicians, clinical data entry accuracy, timeliness and Face to Face encounter accuracy and PCP/MD verification.

New!

Boston, MA6 days ago

$350,000–$400,000 Per Year

Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. 4. Collaborate with cross-functional teams including regulatory affairs, pharmacovigilance, and medical affairs to ensure a holistic approach to product development.

New!

Boston, MAToday

$60,000–$70,000 Per Year

In this role as the Billing Specialist, you will serve as a key point of contact for billing-related questions, respond to attorney and client inquiries, and assist with follow-up on outstanding accounts receivable. By applying to this job, you agree to receive calls, AI-generated calls, text messages, and/or emails from Atrium and its affiliates, and contracted partners.

New!

Devens, MA4 days ago

$43.27–$45.90 Per Hour
Full-time
Employee

Minimum of 2 years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.

Canton, MA13 days ago

Full-time
Employee

Upgrade current WISP to latest version of NIST800-53v5:Continue evaluation comparison of current WISP which is at NIST800-53v4 to newer NIST800-53v5. ECLARO's client is a market-leading insurance company, providing property, casualty, and specialty insurance services within the United States.

Boston, MA30+ days ago

Comfortable working directly for regulatory agencies, including the Food and Drug Administration (FDA), DEA, and Boards of Pharmacies. The Regulatory Affairs Specialist will be responsible for regulatory documentation, compliance, requirements, submissions, and overall regulatory affairs activities.

Cambridge, MA30+ days ago

$130,000–$160,000 Per Year

Participate in regulatory intelligence activities, monitor regulatory guidelines and trends as they pertain to global regulations and guidance, and provide regulatory advice to project teams regarding the applicability/impact on internal programs; anticipate and communicate possible regulatory paradigm shifts. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA.

Brockton, MA30+ days ago

The Specialist responds to patient harm events, learns from individual cases, identifies risk trends, and actively educates leaders, administration, clinicians and staff regarding methods to maximize patient safety and simultaneously reduce professional liability claims. This includes but is not limited to: Development, coordination, and implementation of the continual readiness plan; Ongoing assessment of the continual readiness plan; identification of needed improvements; and preparation and implementation of plans to achieve needed improvements.

Boston, MA8 days ago

Manage line of FDA regulated products: Consumer medical devices (hot/cold packs, pregnancy test kits, drug test kits), OTC drugs (ointments and creams), Cosmetics, Food and Candy. Identifying, researching and gathering relevant information from a variety of sources for regulatory, safety and marketing of product line mentioned.

Somerville, Massachusetts30+ days ago

$120,000–$165,000 Per Year

Regulatory Affairs Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.

Boston, Massachusetts30+ days ago

Overview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.

Somerville, Massachusetts30+ days ago

$133,000–$165,000 Per Year

Lead and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions. Regulatory Affairs Principal is responsible for developing and executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for DeepHealth’s high risk products, including AI technologies.

Watertown, MA30+ days ago

$160,000–$275,000 Per Year

Having advanced the first degrader into the clinic for immunological diseases, Kymera is focused on building an industry-leading pipeline of oral small molecule degraders to provide a new generation of convenient, highly effective therapies for patients with these conditions. As a critical member of a growing RA organization, this role will leverage their recent and relevant hands-on experiences developing immunology treatments to help rapidly advance Kymera's I/I portfolio of targeted protein degraders.

Woburn, MA30+ days ago

Development and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.

Somerville, Massachusetts30+ days ago

$130,000–$160,000 Per Year

Cambridge, MA30+ days ago

$155,000–$190,000 Per Year

Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. In partnership and under guidance from the Regulatory Lead, drive the development of global regulatory strategy for Beam's portfolio of advanced genetic medicines and ensure integration of regulatory tactics that support the broader corporate strategy.

Boston, MA30+ days ago

The Executive Director, Global Regulatory Affairs will provide strategic and operational leadership for global regulatory activities across the company’s oncology portfolio and will be accountable for the development and execution of integrated global regulatory strategies across the full product lifecycle, from early clinical development through registration, commercialization, and post‑approval lifecycle management. Ensure the preparation, review, and approval of high‑quality regulatory submissions and related documentation, including but not limited to INDs/CTAs, scientific advice packages, orphan drug applications, PIPs/PSPs, BLAs/MAAs, labeling strategy and negotiations, responses to regulatory questions, and post‑approval commitments.

Boston, Massachusetts21 days ago

Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration. Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.

Bedford, Massachusetts30+ days ago

Lead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.

Boston, MA30+ days ago

$226,495–$258,817 Per Year

Enrollment in a Phase 2 registration-directed trial of ziftomenib in R/R NPM1-mutant AML has been completed, and in the second quarter of 2025, the companies announced the FDA's acceptance of a New Drug Application for ziftomenib for the treatment of adult patients with R/R NPM1-mutant AML and assignment of a Prescription Drug User Fee Act target action date of November 30, 2025. Ziftomenib, a once-daily, oral menin inhibitor, is the first and only investigational therapy to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration ("FDA") for the treatment of relapsed/refractory ("R/R") NPM1-mutant acute myeloid leukemia ("AML").

Bedford, Massachusetts30+ days ago

$105,000–$130,000 Per Year

Working independently, with guidance from management or senior regulatory staff, the position will participate in cross‑functional software development meetings; prepare software‑specific submission and registration documentation; assess and document software changes, cybersecurity impacts, and algorithm updates. This role is technically focused and requires advanced skills in analyzing software medical device products and regulations, reviewing verification/validation protocols and reports, evaluating risk management documentation, authoring regulatory documents for agile/iterative development environments, and promoting compliance with global digital health requirements.

Waltham, MA24 days ago

$210,000–$270,000 Per Year

Oversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016, EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Own post-market regulatory obligations, including vigilance/adverse event reporting, Field Safety Corrective Actions/recalls (as applicable), regulatory reporting, and support for post-market performance follow-up and performance evaluation report updates under IVDR, as well as post-market surveillance and vigilance requirements under UK MDR 2002.

Boston, MA30+ days ago

$163,000–$182,000 Per Year

This is a critical role for a highly motivated regulatory leader with experience in rare disease drug development, combination products, and a proven track record of advancing programs from early stages through late-phase clinical development. Avalyn is reimagining the future of pulmonary fibrosis treatment with a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease.

Cambridge, MA30+ days ago

$130,000–$190,000 Per Year

Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. Serve as Regulatory lead for PRC/MLR review of promotional, disease awareness, scientific exchange, HCP, and patient-directed materials for certain products, under the supervision of the Director of Regulatory Labelling.

Cambridge, MA30+ days ago

Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. You will work side by side with your regulatory and research and development colleagues to develop and execute innovative regulatory strategies for our fast-paced programs, including the implementation of non-clinical and clinical regualtory strategy for relevant products.

NA, MA11 days ago

Remote

Responsibilities: Lead and provide expert guidance on Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and submissions for biologic products, including monoclonal antibodies, recombinant proteins, vaccines, and cell therapies. Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to develop and execute CMC regulatory strategies aligned with product development objectives.

Boston, MA30+ days ago

You will oversee the preparation and submission of regulatory documents, manage relationships with regulatory agencies, and lead cross-functional teams to support regulatory activities across a variety of projects and therapeutic areas. Oversee and coordinate cross-functional project teams to compile data for regulatory submissions and manage timelines for all regulatory deliverables.

Marlborough, MA8 days ago

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. The Legal Director, Global Regulatory serves in a dual-capacity global role, providing strategic legal leadership across medical device regulatory and quality matters, as well as real-world data (RWD) and real-world evidence (RWE) initiatives.

Malden, MS30+ days ago

Manage regulatory operations activities, including preparation of eCTD submission-ready documents, coordination across functions, and adherence to regulatory guidelines and processes. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines.

Boston, MA30+ days ago

Full-time

At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. This role involves managing the preparation of eCTD submission-ready documents, coordinating across functions, and ensuring quality, accuracy, and adherence to regulatory guidelines.

Boston, MA30+ days ago

$97,000–$105,000

Requires lifting and carrying equipment and supplies weighing up to 35 pounds; requires pushing and pulling equipment and supplies weighing up to 35 pounds; requires walking and standing; requires frequent sitting more than 75% of the workday; requires the ability to negotiate stairs; requires visual acuity and manual dexterity to operate equipment. Through innovative home- and community-based services, Vitra supports aging adults, people with disabilities, and individuals with complex care needs— supported by a Nurse, and Case Manager, Vitra ensures clients receive compassionate, personalized, and dignified care.

NA, MA11 days ago

Remote

Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to ensure efficient and compliant manufacturing operations. Conduct risk assessments and develop risk mitigation strategies for manufacturing processes, equipment, and facilities to ensure product quality and compliance with regulatory requirements.

New!

Bedford, Massachusetts5 days ago

$65,000–$80,000 Per Year

Responsible for assessing customer issues and using judgement and technical expertise to carry out a variety of complaint investigation-related activities, including troubleshooting, investigations, product testing and providing complaint resolution to customers within an FDA regulated environment. Receives, analyzes, and decides best course of action to investigate customer complaints to determine root cause; follows up with customers in a professional, timely manner to close complaints.

Boston, Massachusetts12 days ago

$55–$65 Per Hour

Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. The responsibilities of this position may include, but are not limited to, the following: Participates in cross-functional teams as a Quality technical resource responsible for providing quality oversight and support to manufacturing operations within Vertex or at contracted suppliers .

Woburn, MA30+ days ago

Verify that study documentation (e.g., batch records, raw data, final reports) meets regulatory requirements for data integrity, traceability, and transparency. We are seeking an experienced, detail-oriented, and proactive Quality Assurance (QA) Specialist or Manager with a strong background in auditing regulated bioanalytical LC-MS/MS and ELISA studies.

Boston, Massachusetts30+ days ago

Agreeing to the Atrium Terms and Conditions, includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings, profiles, articles, news, and other employment-related information, as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners. The Quality Specialist works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements.

Franklin, MA30+ days ago

Working in conjunction with the VP Loan Servicing Operations Officer in developing an internal quality assurance auditing program and after identifying areas of concern, the Post Closing/HMDA Quality Assurance Specialist will assist in creating a subsequent training program to enhance post-closing and create efficiencies in loan audits, loan funding, post-closing and servicing. Assist the VP Loan Servicing Operations Officer in developing an internal pre-funding and post-closing Quality Assurance review process identifying adherence to department procedures, bank policies, regulatory compliance and investor guidelines.

New!

Boston, MA5 days ago

Compensation ranges for ASM Research positions vary depending on multiple factors; including but not limited to, location, skill set, level of education, certifications, client requirements, contract-specific affordability, government clearance and investigation level, and years of experience. The physical requirements described in "Knowledge, Skills and Abilities" above are representative of those which must be met by an employee to successfully perform the primary functions of this job.

Plymouth, MA19 days ago

$97,990–$108,880 Per Year

Supports various internal partners by sharing municipal and community knowledge to move projects towards successful outcomes while balancing company and community needs during small-scale project meetings, municipal project briefings, and town/city council, board, commission, committee and other municipal organization meetings. Works with the Community Relations Team to implement strategies for community and municipal outreach and relationship development; emergency preparedness and response; local and regional economic development; strategic corporate giving; and employee engagement, volunteerism, and business membership activities.

Chicopee, MA12 days ago

This role will focus on designing and implementing auditing programs, reviewing audit systems, conducting feedback reviews, and assisting in implementing corrective actions. Assist in developing and implementing quality measurement systems and plans aligned with MHA’s strategic goals, including participation in the annual quality plan preparation.

Bedford, MA30+ days ago

This is a highly collaborative role working closely with Production, Engineering, and Quality teams to support both daily operations and continuous improvement initiatives. The QA Compliance Specialist I is responsible for maintaining product quality and regulatory compliance through documentation review, in-process oversight, and support of quality systems and audit readiness.

Milford, MA8 days ago

This is achieved through a combination of experience in Quality Systems coupled with education and training in Quality Systems, cGMP, Quality audits, documentation, change control, corrective preventative action, validation, calibration, review of quality records, quality metrics, failure investigations and manufacturing and laboratory controls as per cGMPs. Reviewer of project documents (BRs, Technical Reports, Validation documents) Review Certificates of Analysis (COA) and Certificates of Conformance (CoC) for accuracy and release product.

Boston, MA7 days ago

The Bloomberg System Configuration & Trade Support Analyst is responsible for the configuration, maintenance, and oversight of Bloomberg systems supporting trading activities within an introducing broker-dealer environment. This role ensures accurate trade capture, data integrity, reconciliation of trading activity, and alignment between front-office execution, clearing firms, and internal systems.

Stand out to leading employers.

Upload your resume and let employers find you for new Regulatory Specialist job openings. Plus, receive relevant job matches delivered straight to your inbox.

Create A Free Account

Regulatory Specialist Jobs in Massachusetts

Contracts and Compliance Specialist GCR Professional Services

Accounts Payable Specialist Vaco LLC

Senior Payroll Specialist Vaco LLC

Payroll Specialist Vaco LLC

Collections Specialist Vaco LLC

Division Chief-Academic Specialists in General Obstetrics & Gynecology, UMass Memorial Medical Group UMass Memorial Health

Clinical Intake Specialist (Licensed Practical Nurse, LPN, Office) - HomeCare Hartford HealthCare at Home

Vice President Clinical Development Ophthalmology Jobot

Billing Specialist Atrium

TECH SVCS - IT Lab Computing Support Specialist Eclaro

Risk Management and Policy Specialist Eclaro

Regulatory Affairs Specialist CEDENT

Specialist I/II, Regulatory Affairs Beam Therapeutics

Accreditation Regulatory and Risk Management Specialist (Brockton) Boston Medical Center

FDA Regulatory Compliance Specialist MRINetwork

Sr. Regulatory Affairs Spclst Deephealth

Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, Inc

Sr Regulatory Affairs Principal Autonomous Deephealth

Director, Regulatory Affairs Kymera Therapeutics

Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - US

Sr Regulatory Affair Principal Deephealth

Senior Manager, Regulatory Affairs Beam Therapeutics

Executive Director, Regulatory Affairs AVEO Oncology

Manager, Regulatory Affairs Monte Rosa Therapeutics, Inc

Regulatory Affairs Manager II Post Market Werfen

Director, Regulatory Affairs Kura Oncology

Senior Principal Regulatory Affairs Specialis Werfen

Director, Regulatory Affairs Nova Biomedical

Senior Manager / Associate Director, Regulatory Affairs Avalyn Pharma

Manager/Senior Manager Regulatory Affairs – Advertising, Labeling, and Promotion Beam Therapeutics

Associate Director, Regulatory Affairs Relay Therapeutics

Regulatory CMC Expert in Biologics Pharmavise Corporation

Regulatory Manager CEDENT

Legal Director, Global Regulatory Boston Scientific

Associate Director, Regulatory Operations The Steely Group

Associate Director, Regulatory Operations Rhythm Pharmaceuticals

Clinical Compliance Specialist (RN) VITRA Health

Pharmaceutical Manufacturing Specialists with Engineering Background Pharmavise Corporation

Product Complaints Specialist - AID Werfen

GMP Operational Quality Senior Specialist (Contract) 29221 Vertex Pharmaceuticals

Quality Assurance Specialist/Manager – Bioanalytical Laboratory Novabioassays LLC

Learning Quality, Standards Training and Improvement Specialist/Senior Specialist (Contract - Evergreen) Vertex Pharmaceuticals

Post Closing/HMDA Quality Assurance Specialist Dean Bank

ENHD Quality Assurance Specialist ASM Research, An Accenture Federal Services Company

Community Relations Specialist Eversource

Quality Specialist Mental Health Association - Western MA

QA Compliance Specialist Finish Line Staffing Services

Quality Assurance Specialist III Avecia Limited

USA Sr. Specialist, Bloomberg System Configuration & Trade Support Analyst Santander US

Similar Job Searches