Remote Regulatory Affairs Associate Jobs
Remote regulatory affairs associate jobs are open across the U.S. at remote-first firms and distributed teams in pharma, biotech, medical devices, and consumer health. 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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Find JobsRemote Regulatory Affairs Associate 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 associate jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related scientific field
- Hands-on experience preparing or supporting FDA regulatory submissions such as 510(k), NDA, or BLA
- Working knowledge of FDA regulations including 21 CFR Parts 11, 820, and 210/211
- Proficiency with regulatory information management systems and electronic document control software
- Strong technical writing skills demonstrated through SOPs, labeling documents, or regulatory summaries
- Regulatory Affairs Certification (RAC) from RAPS or active candidacy preferred by many employers
Tips for Your Remote Regulatory Affairs Associate Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs associate openings from across the U.S. in one place, so you can find roles that match your background and apply directly without sorting through mixed results from general job sites.
Prove async communication skills upfront
Remote regulatory teams run almost entirely through written channels. Include a writing sample, such as a drafted SOP section, a regulatory summary, or a clear email thread resolving a submission question, in your application materials to show you can communicate precisely without a meeting.
Build fluency with remote submission tools
Remote employers screen for hands-on experience with eCTD publishing software, electronic document management systems, and FDA gateway portals. If you haven't used these in a paid role, get familiar through coursework, practice environments, or regulatory association resources before applying.
Prepare for asynchronous interview stages
Many distributed regulatory teams use recorded video screens or written case exercises before any live interview. Practice explaining a mock submission gap or a labeling discrepancy in writing or on camera so your answers are clear, structured, and self-contained without back-and-forth follow-up.
Remote Regulatory Affairs Associate Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs associate job?
Target companies with fully distributed regulatory teams, such as remote-first biotechs, contract research organizations, and digital health firms that run their submissions workflows entirely online. Remote employers screen heavily for self-direction and written communication, since you'll coordinate with cross-functional teams asynchronously. Demonstrating fluency with regulatory document management systems, eCTD formatting tools, and electronic submission platforms gives you a clear edge over candidates without that hands-on experience.
Which companies hire remote regulatory affairs associates?
Remote regulatory affairs associate 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. Hiring is concentrated among remote-first biotech and medical device firms, contract research organizations, and large pharma companies with distributed regulatory operations teams.
Can you get a remote regulatory affairs associate job with no experience?
Yes, but remote entry-level regulatory affairs associate roles are harder to land because employers expect you to work independently from day one without in-person mentorship. Remote-first biotechs and CROs occasionally hire entry-level candidates who can show completed regulatory coursework, a RAC exam in progress, or volunteer work on submission projects. A writing sample demonstrating clear technical communication goes a long way when direct experience is limited.
Do you need a degree for remote regulatory affairs associate jobs?
Usually, but the field matters more than the prestige of the institution. Most remote employers expect a bachelor's degree in a life sciences, pharmacy, or engineering discipline. What they weigh alongside the degree is hands-on familiarity with FDA submission formats, 21 CFR Part 11 compliance, and document control systems, so candidates who can show real regulatory project work alongside their credentials stand out.
Which industries hire the most remote regulatory affairs associates?
The sectors hiring the most remote regulatory affairs associates are Biotechnology & Pharmaceuticals, Insurance, and Science & Research, based on current remote listings on Migrate Mate as of August 2026. These industries rely on distributed regulatory teams to manage submissions, compliance reviews, and labeling workflows across multiple time zones without requiring staff to be on-site.
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