Remote Regulatory Affairs Manager Jobs
Remote Regulatory Affairs Manager jobs are open across the U.S. at remote-first firms and distributed teams in pharma, medical devices, biotech, and consumer products. Employers hiring remotely right now include Parexel, Amgen, and Oscar Health. See the openings below and apply to the ones that match your experience.
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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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Find JobsRemote Regulatory Affairs Manager Job Market
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 manager jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field
- Hands-on experience preparing and submitting regulatory filings to the FDA or equivalent agencies
- Working knowledge of 21 CFR, ICH guidelines, and applicable international regulatory frameworks
- Regulatory Affairs Certification (RAC) from RAPS preferred or required for senior roles
- Experience with electronic submission systems such as eCTD and regulatory information management software
- Strong written communication skills for authoring regulatory strategies, SOPs, and agency correspondence
Tips for Your Remote Regulatory Affairs Manager Job Search
Show async regulatory work in your materials
Remote employers want evidence you can drive submissions and agency responses without in-person check-ins. Highlight projects where you owned the full regulatory lifecycle in writing, managed comment resolution independently, and communicated decisions clearly to cross-functional teams in different locations.
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs manager openings from across the U.S. in one place, so you can find roles that match your product area and experience level and apply directly before postings fill.
Signal remote readiness in your cover letter
Name the tools you use to manage regulatory timelines and documents remotely, such as electronic submission platforms, document management systems, and project tracking software. Remote hiring managers screen for candidates who already work this way, not ones who will need to be trained on remote habits.
Target distributed biotech and device teams directly
Remote regulatory affairs manager roles concentrate at companies with multi-site operations in biotech, medical devices, and pharmaceuticals. Look for firms with regulatory functions spread across development, manufacturing, and commercial sites, since those organizations have already built remote workflows for regulatory work.
Remote Regulatory Affairs Manager Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs manager job?
Target companies with distributed regulatory teams, which are common in biotech, medical device, and pharmaceutical companies that operate across multiple sites and don't require on-site presence. Remote employers screen heavily for self-direction, precise written communication, and experience managing submissions and agency correspondence without in-person oversight. Candidates who can show they've owned a regulatory project end-to-end, managed timelines independently, and communicated complex requirements in writing stand out most.
Which companies hire remote regulatory affairs managers?
Remote regulatory affairs manager roles are posted by Parexel, Amgen, and Oscar Health and others right now, based on current remote listings on Migrate Mate as of August 2026. The companies hiring this role remotely tend to be remote-first biotech and medical device firms, distributed pharmaceutical teams, and contract research organizations that work across multiple geographies.
Can you get a remote regulatory affairs manager 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 without office mentorship. Smaller biotech startups and contract regulatory consulting firms are more likely to hire junior candidates remotely. A regulatory science certificate, hands-on experience with a submission database, or a demonstrated understanding of FDA or ISO frameworks can substitute for direct job experience.
Do you need a degree for remote regulatory affairs manager jobs?
Usually, but the field weighs relevant experience and demonstrated regulatory knowledge heavily alongside formal credentials. Many remote employers accept candidates with life sciences, engineering, or pharmacy backgrounds regardless of degree level, provided you can show submission experience, agency communication skills, and familiarity with the applicable regulatory frameworks for their product category.
Which industries hire the most remote regulatory affairs managers?
Most remote regulatory affairs manager openings sit in Biotechnology & Pharmaceuticals, Insurance, and Science & Research, per current remote listings on Migrate Mate as of August 2026. Those sectors hire regulatory affairs managers remotely because their teams are already distributed across development sites, manufacturing facilities, and regional offices that don't share a single headquarters.
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