3,413 Results for

Regulatory Affairs Specialist Jobs in the United States

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Jobs

Sunnyvale, CA

$50–$60 / hour
Contractor

p tabindex="0">• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions.

• Provide regulatory guidance to product teams, develop regulatory plans, and review and approve product design control documentation.

2 days ago

Job Posting Only, IL

$92,000–$138,000 / year
Full time

li>

Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.

12 days ago

Work From Home, IL

$92,000–$138,000 / year
Full time

li>Complete and maintain varied regulatory filings by leading internal groups, collaborating with external groups, evaluating and providing direction on supporting technical information, writing appropriate summary documentation, providing direction on product/project changes, and responding to non-conformances and questions from regulators. Prepare comprehensive regulatory strategies for new devices, new launch markets, and post-market device changes, ensuring that the content, context, organization, and quality of supporting information is sufficient to meet all regulatory requirements, commitments, and agreements.

10 days ago

Mundelein

$25–$30 / hour
Temporary
Contractor

The specialist will prepare and submit MDRs through the FDA eMDR portal, including completion of FDA Form 3500A and assignment of appropriate FDA codes. Collabera is looking for an Adverse Event Specialist to review both new and historical product complaints to assess data completeness and determine MDR reportability.

8 days ago

Madison Heights, MI

$26–$26 / hour

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Ensure that our customers and employees are fully informed about the health and safety characteristics of our products and raw materials and that all products marketed by the company are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.).

Provide timely assessments of developmental materials, including chemical materials and formulations, in order to ensure their health and safety, transportation, and disposal considerations are fully understood relative to business impact and customer satisfaction.

7 days ago

Nashville, TN

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Experience in a State DOI, and NAIC, or regulatory agency dealing with insurance financial services, state legislator or political campaign, think-tank public policy organization or trade association, corporate government relations department especially in the financial services industry .

Developing and implementing strategic and advocacy plans for achieving public policy, legislative, and regulatory results in an assigned state and local market that are favorable to the organization and consistent with the overall legislative strategy.

4 days ago

Basking Ridge, NJ

$184,240–$276,360 / year
Full time

p style="margin:0in;line-height:normal;font-size:12pt;font-family:'aptos' , sans-serif">Download Our Benefits Summary PDF.

The Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets.

30+ days ago

Chicago, IL

$79,000–$119,000 / year
Full time

p style="text-align:inherit"/>

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.

30 days ago

Hershey, PA

li>Partner cross-functionally with R&D, Marketing, Legal, Quality, Supply Chain to deliver compliant ingredients, formulas, labels, claims, and certifications for Salty products .

Support Regulatory Affairs activities for Salty Snacks brands, ensuring compliance with U.S. food regulations across the product lifecycle—from ideation through commercialization and post-launch .

7 days ago

Lawrence Township, NJ

$77.58–$82.28 / hour
Full time

Responsibilities:Take on assigned projects to help with development and execution of functionally integrated and aligned medical communications plans; adjust communications plans in accordance with clinical trial results / milestones and changes in the healthcare landscape. In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication.

30+ days ago

Alpharetta, GA

p style="margin:0in;line-height:normal;font-size:11pt;font-family:'aptos' , sans-serif">Here at Avanos Medical, we passionately believe in three things:

Making a difference in our products, services and offers, never ceasing to fight for groundbreaking solutions in everything we do;
Making a difference in how we work and collaborate, constantly nurturing our nimble culture of innovation;
Having an impact on the healthcare challenges we all face, and the lives of people and communities around the world.
Position is based in Alpharetta, GA with the ability to work at least three days a week (ideally Tuesday-Thursday) in officeand be available for onsite workshops when required.

Today

New York, NY

$35–$41

p>This position will primarily support hiring for Resource Development, Marketing, and Communications teams, including roles within Development/Fundraising, Public Affairs, Corporate Communications, and Marketing & Communications.

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.

3 days ago

Marion, OH

p style="text-align:inherit">Drives program growth, quality outcomes, patient attribution, recruitment, acquisitions, service excellence, and fiscal targets by collaborating across OhioHealth, Clinical Enterprise, Population Health, and Acute Care operations in a matrixed environment.

Reporting to the Vice President of Acute Care Services, the Vice President Clinical Affairs (VPCA), directs and coordinates the clinical affair activities of OhioHealth, for specifically assigned care sites.

3 days ago

Los Angeles, CA

$30–$35

p> 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.
Canadian residents may access our policies in English here and in French here.

3 days ago

Remote, OR

Remote

$11.90–$22.10

Our passionate, global workforce augments local expertise and diverse mix of skills with data, science, and technology to deliver bespoke engagement solutions that help clients reimagine how they engage with their patients, payers, people, and providers to improve treatment outcomes.

Inizio Engage has a long-standing partnership with a leading Biotechnology company, across Commercial, Patient Solutions and Medical Affairs businesses.

Today

Remote, OR

Remote

$11.90–$22.10

Learn more: https://www.greatplacetowork.com/certified-company/7003732 .

Today

Chicago

$28–$30 / hour
Temporary
Contractor

5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry Strong working knowledge of FDA Medical Device Reporting regulations (21 CFR 803) and complaint handling requirements (21 CFR 820.198) Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A Ability to evaluate complaint narratives, determine reportability, and apply FDA coding for adverse events, malfunctions, injuries, and deaths Strong verbal and written communication skills with the ability to collaborate effectively across Quality, Regulatory Affairs, R&D, and Operations teams Experience with quality documentation processes, verification activities, DMR/DMRC documentation, and HIPAA-compliant recordkeeping Proficiency with MS Suite and complaint management systems such as SAP, TrackWise, or similar platforms Bachelor’s degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Healthcare, or a related field Mission: Support post-market surveillance and regulatory compliance efforts by reviewing product complaints, determining MDR reportability, and ensuring all adverse event submissions are completed accurately and in accordance with FDA requirements, including 21 CFR 803 and Quality System regulations.

10 days ago

Mundelein

$25–$30 / hour
Temporary
Contractor

Job Description: 5 years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry. Experience preparing and submitting MDRs through the FDA eMDR portal, including completion of FDA Form 3500A.

9 days ago

Mundelein

$28–$30 / hour
Temporary
Contractor

Job Title: MDR SpecialistDuration: 6 Months Contracts with possible extension/conversionLocation: Mundelein, IL 60060 (HYBRID, 3 Day Onsite and 2 Day Remote)Pay Range: $28/hr - $30/hrMust Haves: 5+ years of experience in complaint handling, adverse event reporting, MDR evaluation, post-market surveillance, or regulatory affairs within the medical device or pharmaceutical industry.

9 days ago

South Brunswick, NJ

$31–$35 / hour

li> Evaluate deviations, investigations, change controls, out-of-specification (OOS) and out-of-trend (OOT) events, and CAPA activities, including root cause analysis and quality impact assessments. Required Experience/Skills for the QA Data Review & Compliance Specialist:

3 - 5 years of experience in Quality Assurance, Quality Systems, Compliance, Auditing, or Data Review within a pharmaceutical, biotechnology, or regulated life sciences environment.

8 days ago

Roanoke, LA

Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. Posting Title: Family Nurse Practitioner / Physician Assistant Overview:

In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction.

21 days ago

Jennings, LA

21 days ago

Knoxville, TN

$88,000–$163,000

We are seeking a Clinical Educator to deliver educational support to identified Healthcare Professionals and office staff within primary care and specialist facilities in the field of a designated disease state.

8 days ago

Midway, TN

Posting Title: Family Nurse Practitioner / Physician Assistant Overview: In a manner consistent and supportive of our values, the Provider is responsible for delivering high quality health care within Fast Pace Health’s scope of services while achieving optimum patient satisfaction. They must have the ability to respond quickly and accurately to changes in condition or response to treatment and is responsible for providing outstanding patient service within the clinic and through various virtual communication channels, while maintaining a compassionate and welcome atmosphere.

30+ days ago

Greens Fork, IN

1 day ago

Grenada, MS

1 day ago

Brookville, IN

26 days ago

Monticello, KY

3 days ago

Sweeden, KY

29 days ago

Louisville, KY

26 days ago

Milton, IN

1 day ago

Clarkson, KY

Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf.

3 days ago

Manila, AR

Please refer to the links below for information regarding your rights under certain federal laws: https://www.dol.gov/sites/dolgov/files/WHD/legacy/files/fmlaen.pdf. https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf.

26 days ago

Jasper, AL

1 day ago

Plymouth, NC

26 days ago

Rocky Mount, NC

26 days ago

Belews Creek, NC

26 days ago

Morganton, NC

11 days ago

Cambridge, MA

$220–$320 / hour

This is an opportunity to provide clinical leadership in developing RNAi therapeutics in client's rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. The Senior Director, Clinical Research, will work in a matrix organization across Regulatory, Biostatistics, Clinical Operations, Preclinical, Commercial & QA teams to ensure fully harmonized and integrated development strategies.

2 days ago

Cambridge, MA

$220–$320 / hour

This is an opportunity to provide clinical leadership in developing RNAi therapeutics, rapidly expanding portfolio, which spans the areas of rare genetic diseases, cardio-metabolic diseases, neuroscience, hematology and hepatology. While the primary focus responsibility will be as clinical lead physician on client's autoimmune liver disease programs, the role may support across a range of therapeutic areas and all stages of development may be required as pipeline assets evolve.

2 days ago

Hanover, IN

5 days ago

Sparks, Nevada

Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. They coordinate and support worldwide product registration requests, interface with global international regulatory and marketing contacts to support regional registration requirements and develop/maintain department procedures for international product registrations.

23 days ago

Connecticut

The Regulatory Affairs Specialist 1 will independently monitor their workload intensity and track deadlines to ensure prompt submission and/or completion and proper regulatory reporting and compliance deliverables are met, including recording and reporting requisite metrics for CTO leadership and departmental stakeholders. Collaborating directly with investigators, sponsors, and other key stakeholders within Yale CTO, as well as colleagues across the research enterprise, this role participates in the advancement of critical strategic objectives that promote effective, efficient, and compliant management of Cancer Center clinical research studies.

3 days ago

Salt Lake City, UT

$43,945–$62,527 / year

li>Provide support to the CTSI to 1) ensure compliance with the NIH Public Access Policy for all articles associated with the CTSI, including assisting authors with the process, and 2) develop and refine programming (web materials, presentations, etc) to promote awareness of this requirement throughout the timeline of an investigator/author's involvement with any CTSI core(s).

Open Date 04/30/2026 Requisition Number PRN44883B Job Title Regulatory Affairs Specialists Working Title QA/QC Navigator Career Progression Track P00 Track Level P2 - Developing, P1 - Entry Level Pro FLSA Code Professional Patient Sensitive Job Code?

30+ days ago

Allen, TX

p>Alternatively, will accept a Master's degree in Regulatory Affairs, Healthcare Policy, Healthcare Management, or related field and three (3) years of experience as a Senior Regulatory Affairs Specialist, International Regulatory Affairs Specialist, Regulatory Affairs Specialist, Regulatory Affairs Co-Ordinator, or related role where experience was gained, plus the special skills listed above.

Requirements: Bachelor's degree in Regulatory Affairs, Healthcare Policy, Healthcare Management, or related field and five (5) years of experience as a Senior Regulatory Affairs Specialist, International Regulatory Affairs Specialist, Regulatory Affairs Specialist, Regulatory Affairs Co-Ordinator, or related role where experience was gained.

11 days ago

Rocky Hill, CT

Full time

on W2 (Without benefits) Job Description Responsibilities: Ensure that our customers and employees are fully informed about the health and safety characteristics of our products and raw materials and that all products marketed by Henkel Corporation are in compliance with all appropriate regulations (Federal, State, County, regional and/or local.) Provide timely assessments of developmental materials, including chemical materials and formulations, in order to assure that their health and safety, transportation, and disposal considerations are fully understood relative to business impact and customer satisfaction.

30+ days ago

p style="min-height:1.5em">Archy is a Series B vertical SaaS solution revolutionizing the dental practice management space — giving dental providers AI agents and software that lets them do what they do best (be dentists!) while we handle the more technical sides of running their practice business.

Run the post-market program for Archy Imaging: complaint handling, MDR reporting, post-market surveillance, labeling reviews, and any future FDA correspondence including pre-submissions and inspection readiness.

30+ days ago

div>

Adoption assistance, backup day care and eldercare, support for neurodivergent adults, children, and caregivers, caregiving assistance for elderly and special needs individuals, Employee Assistance Program (EAP), paid parental leave, support for fertility, birthing, postpartum, and age-related hormonal changes.

Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations.

30+ days ago

Columbia, SC

This entry-level role assists with regulatory documentation, tracking submissions, and maintaining compliance records while gaining hands-on experience with regulatory processes under supervision. Qualifications: + Bachelor of Science Degree (degree in Regulatory Affairs preferred) with no professional experience or Associates Degree in a scientific discipline with at least two years of professional experience in pharmaceutical industry .

30+ days ago

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Regulatory Affairs Specialist Jobs in the United States

Regulatory Affairs Specialist DGN Technologies Inc

Senior Regulatory Affairs Specialist Medline Industries

Sr. Regulatory Affairs Specialist Medline Industries

Regulatory Affairs Specialist Collabera

Regulatory Affairs Specialist Joulé

Government Affairs Executive Sentry Insurance

Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.

Regulatory Labeling Specialist Medline Industries

Regulatory Specialist / Food Science System One

Medical and Regulatory Affairs - Cell Therapy Medical Communication Specialist Eclaro

Senior Regulatory Intelligence Specialist - Alpharetta, GA Avanos Medical

Talent Acquisition Specialist Vaco LLC

VP Clinical Affairs, Marion General Hospital OhioHealth

Documentation Specialist Vaco LLC

Patient Access Specialist Inizio Engage

Contact Center Patient Access Specialist Inizio Engage

Events Specialist Collabera

Adverse Event Specialist Collabera

MDR Specialist Collabera

QA Data Review & Compliance Specialist Atrium

Family Nurse Practitioner / Physician Assistant - Flexible Schedules Fast Pace Health

Family Nurse Practitioner / Physician Assistant - Growth Opportunity Fast Pace Health

Clinical Educator Inizio Engage

Family Nurse Practitioner / Physician Assistant Fast Pace Health

ARNP Fast Pace Health

Family Nurse Practitioner Fast Pace Health

PRN Family Nurse Practitioner Fast Pace Health

Family Nurse Practitioner - Flexible Schedules Fast Pace Health

PRN - Family Nurse Practitioner Fast Pace Health

Family Nurse Practitioner- Up To $4,000 Relocation Assistance Fast Pace Health

Family Nurse Practitioner - 35$ Clinic Visits for Family Members Fast Pace Health

Family Nurse Practitioner - $5K Sign On Bonus! Fast Pace Health

Family Nurse Practitioner - $10k Sign-On + Extensive New Grad Training! Fast Pace Health

Family Nurse Practitioner / Physician Assistant - New Grad Opportunity with Extensive Training Program! Fast Pace Health

Family Nurse Practitioner / Physician Assistant – Join Our Team + $5,000 Bonus Fast Pace Health

Family Nurse Practitioner / Physician Assistant - $5k Sign-On Bonus Fast Pace Health

Family Nurse Practitioner / Physician Assistant - $2,500 Sign - On Bonus Fast Pace Health

Family Nurse Practitioner / Physician Assistant (Float) Fast Pace Health

Senior Medical Director, Clinical Research - Neurodegeneration - 6 TalentBurst, Inc.

Senior Medical Director, Clinical Research - Hepatology - 6 TalentBurst, Inc.

Family Nurse Practitioner/Physician Assistant Fast Pace Health

International Regulatory Affairs Specialist Becton Dickinson Medical Devices

Regulatory Affairs Specialist Yale University

Regulatory Affairs Specialists University of Utah

Senior Specialist, Regulatory Affairs and Compliance Nordson Corp

Regulatory Affairs Specialist Regulatory Affairs Specialist LanceSoft Inc

Regulatory Affairs Specialist Archy

Regulatory Affairs Specialist Becton Dickinson Medical Devices

Regulatory Affairs Specialist The Ritedose Corporation

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