Remote Regulatory Affairs Jobs
Remote Regulatory Affairs jobs are open across the U.S. in pharmaceuticals, medical devices, biotech, and food and consumer products, at companies ranging from emerging startups to established multinationals with distributed compliance teams. Employers hiring remotely right now include Parexel, Amgen, and Oscar Health. Find a role that fits below and apply directly.
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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 jobs.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related field
- Experience with FDA submissions including INDs, NDAs, BLAs, or 510(k)s
- Knowledge of 21 CFR regulations and ICH guidelines
- Proficiency with regulatory information management systems such as Veeva Vault
- Regulatory Affairs Certification (RAC) from RAPS preferred or required
- Strong technical writing skills for regulatory documents and agency correspondence
Tips for Your Remote Regulatory Affairs Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs openings from across the U.S. in one place, so you can find roles that match your background and apply directly without sorting through general job boards. Remote postings fill fast, so applying as soon as a role appears gives you a real advantage.
Prove you can work asynchronously
Remote regulatory affairs employers want candidates who communicate clearly in writing without back-and-forth. Build a short portfolio of regulatory documents you have authored or edited, such as SOPs, labeling drafts, or briefing documents, and be ready to share them as work samples during screening.
Show fluency in remote regulatory tools
Mention eCTD authoring platforms, document management systems like Veeva Vault, and regulatory intelligence tools by name in your application materials. Remote teams assume you will operate these independently from day one, so naming the specific software you have used signals you are ready to contribute without onboarding delays.
Target companies with distributed compliance teams
Prioritize remote-first biotech firms, CROs, and medical device companies with offices across multiple time zones. These organizations have already built the infrastructure and management practices for remote regulatory work, which means faster ramp-up and clearer remote expectations than companies hiring their first fully remote regulatory hire.
Remote Regulatory Affairs Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs job?
Target companies that already run distributed regulatory teams, such as remote-first biotech firms, medical device companies with global operations, and contract research organizations. Remote regulatory affairs employers screen hard for self-direction, precise written communication, and the ability to manage submissions and agency correspondence without in-person oversight. Proficiency with eCTD authoring tools, document management systems, and regulatory intelligence platforms gives candidates a clear edge over applicants with comparable experience but no remote work background.
Which companies hire remote regulatory affairss?
Employers currently hiring remote regulatory affairss include Parexel, Amgen, and Oscar Health, per current remote listings on Migrate Mate as of August 2026. Remote-first biotech and medical device companies, CROs, and multinational consumer goods firms make up the largest share of openings because their regulatory functions are designed to operate across distributed teams.
Can you get a remote regulatory affairs job with no experience?
Yes, but remote entry-level regulatory affairs roles are harder to land because employers expect you to manage submissions and navigate agency requirements independently from day one. Smaller biotech startups and CROs are most likely to hire junior remote candidates. Showing completed regulatory coursework, a RAC exam in progress, or hands-on project work from an internship or academic program compensates for a thin work history and signals you can operate without daily supervision.
Do you need a degree for remote regulatory affairs jobs?
Usually, but the field of study matters more than the credential itself. Most remote employers expect a degree in a life sciences, pharmacy, or engineering discipline because regulatory submissions require technical fluency. That said, candidates who can demonstrate hands-on submission experience, regulatory intelligence skills, or a RAC certification can offset a non-traditional academic background, particularly at companies hiring for defined functional roles rather than broad regulatory generalist positions.
Which industries hire the most remote regulatory affairss?
The sectors hiring the most remote regulatory affairss are Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of August 2026. These sectors post the highest volume of remote openings because their regulatory workflows, including dossier preparation, agency correspondence, and labeling review, translate cleanly to distributed team structures.
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