Remote Regulatory Affairs Specialist Jobs
Remote regulatory affairs specialist jobs are open across the U.S. in pharmaceutical, biotech, medical device, and consumer products companies, from entry-level regulatory coordinators to senior directors managing global submissions on distributed teams. Employers hiring remotely right now include Parexel, Amgen, and Oscar Health. Scan the live roles below and apply to whichever ones fit.
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Regulatory Affairs Leader
Req Id: 2097
State/Province: Arizona
Business: Gore Medical Products
Category: Clinical & Regulatory
Sub-Category: Clinical
Work Arrangement: Remote
Posting Start Date: 8/12/26
Posting End Date: 8/27/26
About the Role
We are looking for a Regulatory Affairs Leader to join our team with the Aortic Business Group. In this role, you will p lan, develop, and prepare regulatory strategies and coordinate regulatory planning aimed at achieving and maintaining global marketing approvals or clearances for new, modified, and existing products. In addition, you will p rovide direction and leadership for Regulatory Associates with a focus to develop global regulatory strategies and provide guidance and support for comprehensive global submission planning.
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities
Provide direction for regulatory team members for both pre- and post-market product strategies, comprehensive submission planning, regulatory agency discussions, and approval timelines
Provide management and leadership for Regulatory Associate’s goals, objectives, projects and responsibilities
Lead and manage activities that create and improve the Regulatory function and Gore Medical by facilitating accurate, timely, and consistent regulatory compliance, submissions, and regulatory processes
Work together with cross-functional teams (e.g., Clinical, Product Specialists, and Technical) to ensure open communication and that expectations are being met
Partner with Regulatory Affairs Business Leader to ensure business and regulatory goals are met
Share regulatory knowledge and experience to assist Regulatory Associates in developing expertise on regulatory deliverables and requirements, including labeling, promotional advertising, and other regulatory compliance areas
Ensure communication of changing global regulatory requirements both within the function and with other functional teams
Additional responsibilities as required within the scope of position
Required Qualifications
Bachelor’s degree and at least 8 years of experience in medical device Regulatory Affairs
Extensive knowledge of FDA and international regulations related to Class III implantable medical devices and hands-on experience with PMA products
Proven track record in managing complex global regulatory strategies
Experience actively working with cross-functional teams to influence the direction and meet timelines
Willingness to share experience and coach Regulatory Associates in order to successfully execute on regulatory assessments, submission strategy, and submission writing
Experience with regulatory strategies and/or submission planning with shifting timelines
Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, packaging, or sterilization
Experience with direct people leadership
Ability to prioritize work and adapt to shifting priorities
Demonstrated communication and organizational skills and ability to travel up to 15%
Desired Qualifications
Experience with Custom Made Device and/or Patient Matched device regulatory requirements and pathways
Experience with regulatory clinical pathways including IDEs
Advanced degree or RAC certification
This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.
- Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.
Regulatory Affairs Leader
Req Id: 2097
State/Province: Arizona
Business: Gore Medical Products
Category: Clinical & Regulatory
Sub-Category: Clinical
Work Arrangement: Remote
Posting Start Date: 8/12/26
Posting End Date: 8/27/26
About the Role
We are looking for a Regulatory Affairs Leader to join our team with the Aortic Business Group. In this role, you will p lan, develop, and prepare regulatory strategies and coordinate regulatory planning aimed at achieving and maintaining global marketing approvals or clearances for new, modified, and existing products. In addition, you will p rovide direction and leadership for Regulatory Associates with a focus to develop global regulatory strategies and provide guidance and support for comprehensive global submission planning.
This is a remote position, and you can work from home in most locations within the United States.
Responsibilities
Provide direction for regulatory team members for both pre- and post-market product strategies, comprehensive submission planning, regulatory agency discussions, and approval timelines
Provide management and leadership for Regulatory Associate’s goals, objectives, projects and responsibilities
Lead and manage activities that create and improve the Regulatory function and Gore Medical by facilitating accurate, timely, and consistent regulatory compliance, submissions, and regulatory processes
Work together with cross-functional teams (e.g., Clinical, Product Specialists, and Technical) to ensure open communication and that expectations are being met
Partner with Regulatory Affairs Business Leader to ensure business and regulatory goals are met
Share regulatory knowledge and experience to assist Regulatory Associates in developing expertise on regulatory deliverables and requirements, including labeling, promotional advertising, and other regulatory compliance areas
Ensure communication of changing global regulatory requirements both within the function and with other functional teams
Additional responsibilities as required within the scope of position
Required Qualifications
Bachelor’s degree and at least 8 years of experience in medical device Regulatory Affairs
Extensive knowledge of FDA and international regulations related to Class III implantable medical devices and hands-on experience with PMA products
Proven track record in managing complex global regulatory strategies
Experience actively working with cross-functional teams to influence the direction and meet timelines
Willingness to share experience and coach Regulatory Associates in order to successfully execute on regulatory assessments, submission strategy, and submission writing
Experience with regulatory strategies and/or submission planning with shifting timelines
Demonstrated success regarding the assessment of proposed changes to medical device design, specifications, materials, manufacturing methods or equipment, packaging, or sterilization
Experience with direct people leadership
Ability to prioritize work and adapt to shifting priorities
Demonstrated communication and organizational skills and ability to travel up to 15%
Desired Qualifications
Experience with Custom Made Device and/or Patient Matched device regulatory requirements and pathways
Experience with regulatory clinical pathways including IDEs
Advanced degree or RAC certification
This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.
- Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.
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Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals11
- Insurance3
- Science & Research2
- Manufacturing1
- Banking & Financial Services1
What Employers Look For
The qualifications that appear most often in remote regulatory affairs specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field
- Experience preparing and submitting regulatory filings such as 510(k), PMA, NDA, or BLA
- Knowledge of FDA regulations including 21 CFR parts relevant to the product type
- Proficiency with regulatory information management systems such as Veeva Vault or RIMS
- Regulatory Affairs Certification (RAC) from RAPS preferred for senior roles
- Strong technical writing skills for preparing regulatory summaries, briefing documents, and SOPs
Tips for Your Remote Regulatory Affairs Specialist Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs specialist openings from across the U.S. in one place, so you can find roles that match your background and apply directly. Remote postings attract high applicant volume fast, so applying within the first few days of a listing matters.
Show async communication skills upfront
Remote regulatory affairs employers prioritize candidates who can communicate precisely in writing without real-time back-and-forth. In your cover letter and resume, highlight experience writing submission summaries, SOPs, or regulatory correspondence that others acted on without clarifying calls.
Demonstrate fluency with remote regulatory tools
Call out your hands-on experience with document management and submission platforms like Veeva Vault, MasterControl, or eCTD publishing tools. Remote teams cannot afford onboarding time for software basics, so naming specific platforms signals you can contribute from day one.
Target companies with established distributed teams
Remote regulatory affairs roles are most stable at companies that already run distributed regulatory or clinical teams, not those testing remote work for the first time. Look for job descriptions that reference cross-functional remote collaboration, multiple time zones, or global regulatory strategy.
Remote Regulatory Affairs Specialist Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs specialist job?
Remote regulatory affairs specialist roles go to candidates who can demonstrate self-direction, precise written communication, and fluency with document management systems like Veeva Vault or MasterControl. Remote employers screen heavily for async collaboration skills, comfort with cross-functional digital workflows, and the ability to manage submissions and timelines without in-person oversight. Certifications like RAC from RAPS give your application a concrete edge over generalist candidates.
Which companies hire remote regulatory affairs specialists?
Companies hiring remote regulatory affairs specialists right now include Parexel, Amgen, and Oscar Health, based on current remote listings on Migrate Mate as of August 2026. Remote regulatory affairs roles concentrate at pharmaceutical companies, medical device manufacturers, biotech firms, and contract research organizations that operate distributed regulatory teams across multiple markets.
Can you get a remote regulatory affairs specialist job with no experience?
Yes, but remote entry-level regulatory affairs roles are harder to land because employers expect you to work independently from day one with minimal supervision. Your strongest entry points are contract research organizations and startups that hire junior regulatory coordinators remotely. In place of experience, show familiarity with FDA submission processes, regulatory databases, and document control tools, and highlight any coursework, internships, or independent projects involving compliance or technical writing.
Do you need a degree for remote regulatory affairs specialist jobs?
Usually, but the field is more credential-flexible than many assume. Most remote employers prefer a bachelor's in a life sciences, chemistry, or engineering discipline, but candidates who hold RAC certification and can show hands-on submission experience, strong technical writing, and working knowledge of FDA or international regulatory frameworks are competitive even without a traditional degree path.
Which industries hire the most remote regulatory affairs specialists?
The sectors hiring the most remote regulatory affairs specialists are Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of August 2026. These industries hire regulatory affairs specialists remotely because their submission, compliance, and labeling work is documentation-driven and integrates naturally into distributed team structures across time zones.
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