Remote Regulatory Affairs Director Jobs
Remote regulatory affairs director jobs are open across the U.S. at remote-first firms and distributed teams in life sciences, medical devices, pharmaceuticals, and biotech. 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 Director 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 director jobs.
- Bachelor's or advanced degree in life sciences, pharmacy, chemistry, or a related field
- Eight or more years of regulatory affairs experience in pharmaceuticals, biologics, or medical devices
- Demonstrated experience leading FDA submissions including INDs, NDAs, BLAs, or 510(k)s
- RAC certification from the Regulatory Affairs Professionals Society preferred or required
- Proficiency with electronic submissions, eCTD format, and regulatory information management systems
- Experience managing regulatory teams and cross-functional project timelines from submission through approval
Tips for Your Remote Regulatory Affairs Director Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs director openings from across the U.S. in one place, so you can find roles that match your background and apply directly. Remote postings fill faster than on-site ones, so acting early gives you a real advantage.
Prove async regulatory work in your resume
Remote employers want evidence you've led submissions, responded to agency queries, and managed cross-functional input without relying on in-person coordination. Call out specific regulatory milestones you owned remotely, the tools you used, and how you kept distributed teams aligned throughout.
Build a written regulatory communication sample
Remote regulatory directors are judged heavily on written clarity. Prepare a short, polished writing sample, such as a redacted regulatory briefing, a strategy memo, or an agency response summary, that shows how you communicate complex requirements without a meeting.
Target distributed biotech and medtech companies directly
Many remote regulatory affairs director roles never appear on broad job boards. Research remote-first biotech firms, digital health companies, and contract research organizations that list remote work as a structural part of their regulatory function, then apply directly to open roles.
Remote Regulatory Affairs Director Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs director job?
Target remote-first biotech, medtech, and pharmaceutical companies that run distributed regulatory teams, since those organizations are built to support a director who works independently without an on-site team. Remote employers screen heavily for self-direction, clear written communication, and experience managing submissions and agency interactions without daily oversight. A demonstrated history of leading regulatory strategy across asynchronous teams and comfort with collaboration tools like Slack and document management platforms gives candidates a real edge.
Which companies hire remote regulatory affairs directors?
Remote regulatory affairs director 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. Remote-first biotech firms, distributed medical device companies, and pharmaceutical consultancies make up the bulk of employers posting these roles with no location requirement.
Can you get a remote regulatory affairs director job with no experience?
Yes, but remote director-level roles are harder to land without experience because you're expected to operate independently from day one with minimal supervision. Remote-first companies hiring at the entry edge of this title look for candidates who can show regulatory project ownership, even from contract work, a consultancy, or a senior specialist role where you led submissions. Demonstrating async work habits, strong written regulatory communication, and familiarity with eCTD or 510(k) processes opens the door faster than a title alone.
Do you need a degree for remote regulatory affairs director jobs?
Usually, but the field weighs demonstrated regulatory outcomes alongside credentials. Most remote employers expect a degree in a life sciences, engineering, or related technical field, and RAC certification from RAPS strengthens any application. What matters most at the director level is a record of successful submissions, agency interactions, and regulatory strategy, and candidates who can clearly document those results are competitive even if their degree is in a related but not exact discipline.
Which industries hire the most remote regulatory affairs directors?
Remote regulatory affairs director roles concentrate in Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of August 2026. Those sectors have adopted distributed team structures that allow regulatory directors to manage submissions, lead cross-functional strategy, and coordinate with agencies entirely off-site.
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