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 Pace Analytical Services, Parexel, and IQVIA. Find a role that fits below and apply directly.
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Showing 5 of 94+ Remote Regulatory Affairs jobs
Date: Sep 25, 2026
Location: Remote, MA, US
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 14464
Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.
Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
For more information, please visit Ingenyx.com
Position Summary
The Regulatory Affairs Coordinator supports the Quality and Regulatory Affairs organization through regulatory intelligence, standards management, regulatory change coordination, regulatory authority interactions, and U.S. import regulatory compliance.
This role serves as the central coordinator for regulatory and standards information and as a key resource for FDA and U.S. Customs and Border Protection (CBP) import requirements, including FDA Automated Commercial Environment (ACE) activities.
Principal Responsibilities
- Support ongoing Quality and Regulatory Affairs (QARA) intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance by maintaining the organization's Standards e-system, standards watchlists, and applicable standards inventory.
- Maintain regulatory intelligence records, trackers, and supporting documentation.
- Coordinate the Regulatory Change Notification process for changes potentially affecting registrations, licenses, certifications, technical documentation, labeling, or regulatory commitments.
- Maintain regulatory correspondence and supporting records.
- Serve as the QARA subject matter resource for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import requirements.
- Coordinate and maintain FDA ACE data required for imported finished goods, components, raw materials, and other regulated articles.
- Support creation, review, and maintenance of FDA-related master data in business systems such as SAP ECC6, SAP MDG, or other applicable enterprise systems, including establishment names and addresses, manufacturer/exporter information, importer-of-record details, FDA product codes, device listing references, and regulatory identifiers.
- Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation of regulated products and materials.
- Support resolution of FDA/CBP import-entry issues, to include coordination of responses to FDA Notices of Action, entry holds, detentions, requests for documents, or other FDA/CBP import-entry inquiries in partnership with Trade Compliance, customs brokers, and appropriate internal SMEs.
- Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation of applicable changes.
- Serve as an administrative point of contact for Notified Bodies and regulatory authorities, under the direction of Regulatory Affairs leadership.
- Track regulatory commitments, requests for information, audit actions, and required responses.
- Support regulatory inspections, assessments, and Notified Body audits.
- Maintain regulatory trackers, databases, certificates, licenses, registrations, and related documentation.
- Support preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications.
- Prepare routine regulatory status reports and metrics.
Education / Experience Requirements
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred.
- 3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment.
- Experience with FDA ACE requirements and medical device importation strongly preferred.
- Working knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements.
- Familiarity with U.S. Customs and Border Protection (CBP) processes and working with customs brokers.
- Familiarity with ISO 13485, FDA medical device requirements, and EU MDR.
- Experience with regulatory intelligence or standards-management systems preferred.
- Strong organizational, analytical, and project-coordination skills.
- Strong attention to detail and ability to manage multiple regulatory deadlines.
- Effective written and verbal communication skills.
Specialized Skills / Other Requirements
- Regulatory intelligence and standards monitoring
- Regulatory change coordination
- FDA ACE and medical device import compliance
- FDA/CBP regulatory requirements
- Regulatory authority and Notified Body coordination
Role Boundaries
The RA Coordinator serves as the operational SME for established FDA ACE and import-compliance processes and coordinates routine regulatory activities.
Complex regulatory strategy, legal interpretations, significant regulatory commitments, reportability decisions, and novel or high-risk import matters are escalated to Regulatory Affairs leadership, Trade Compliance, Legal, or other appropriate subject matter experts.'
#LI-AD1
The pay range for this position at commencement of employment is expected to be between $65,700- $85,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
At Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Ingenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Nearest Major Market: Worcester
Date: Sep 25, 2026
Location: Remote, MA, US
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 14464
Ingenyx proudly launched as a new, independent company following its divestiture from Teleflex on August 3, 2026.
Ingenyx is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.
For more information, please visit Ingenyx.com
Position Summary
The Regulatory Affairs Coordinator supports the Quality and Regulatory Affairs organization through regulatory intelligence, standards management, regulatory change coordination, regulatory authority interactions, and U.S. import regulatory compliance.
This role serves as the central coordinator for regulatory and standards information and as a key resource for FDA and U.S. Customs and Border Protection (CBP) import requirements, including FDA Automated Commercial Environment (ACE) activities.
Principal Responsibilities
- Support ongoing Quality and Regulatory Affairs (QARA) intelligence activities by monitoring new and changing regulations, standards, and regulatory guidance by maintaining the organization's Standards e-system, standards watchlists, and applicable standards inventory.
- Maintain regulatory intelligence records, trackers, and supporting documentation.
- Coordinate the Regulatory Change Notification process for changes potentially affecting registrations, licenses, certifications, technical documentation, labeling, or regulatory commitments.
- Maintain regulatory correspondence and supporting records.
- Serve as the QARA subject matter resource for FDA Automated Commercial Environment (ACE) and FDA/CBP medical device import requirements.
- Coordinate and maintain FDA ACE data required for imported finished goods, components, raw materials, and other regulated articles.
- Support creation, review, and maintenance of FDA-related master data in business systems such as SAP ECC6, SAP MDG, or other applicable enterprise systems, including establishment names and addresses, manufacturer/exporter information, importer-of-record details, FDA product codes, device listing references, and regulatory identifiers.
- Partner with Trade Compliance, Supply Chain, Logistics, Customs Brokers, and Regulatory Affairs to support compliant importation of regulated products and materials.
- Support resolution of FDA/CBP import-entry issues, to include coordination of responses to FDA Notices of Action, entry holds, detentions, requests for documents, or other FDA/CBP import-entry inquiries in partnership with Trade Compliance, customs brokers, and appropriate internal SMEs.
- Monitor changes to FDA/CBP import requirements and coordinate assessment and implementation of applicable changes.
- Serve as an administrative point of contact for Notified Bodies and regulatory authorities, under the direction of Regulatory Affairs leadership.
- Track regulatory commitments, requests for information, audit actions, and required responses.
- Support regulatory inspections, assessments, and Notified Body audits.
- Maintain regulatory trackers, databases, certificates, licenses, registrations, and related documentation.
- Support preparation, compilation, formatting, and administrative processing of regulatory submissions and notifications.
- Prepare routine regulatory status reports and metrics.
Education / Experience Requirements
- Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, Supply Chain, Business, or related discipline preferred.
- 3–5 years of experience in Regulatory Affairs, Regulatory Operations, Quality, Trade Compliance, or a related medical device environment.
- Experience with FDA ACE requirements and medical device importation strongly preferred.
- Working knowledge of FDA medical device establishment registration, device listing, product codes, and import-entry requirements.
- Familiarity with U.S. Customs and Border Protection (CBP) processes and working with customs brokers.
- Familiarity with ISO 13485, FDA medical device requirements, and EU MDR.
- Experience with regulatory intelligence or standards-management systems preferred.
- Strong organizational, analytical, and project-coordination skills.
- Strong attention to detail and ability to manage multiple regulatory deadlines.
- Effective written and verbal communication skills.
Specialized Skills / Other Requirements
- Regulatory intelligence and standards monitoring
- Regulatory change coordination
- FDA ACE and medical device import compliance
- FDA/CBP regulatory requirements
- Regulatory authority and Notified Body coordination
Role Boundaries
The RA Coordinator serves as the operational SME for established FDA ACE and import-compliance processes and coordinates routine regulatory activities.
Complex regulatory strategy, legal interpretations, significant regulatory commitments, reportability decisions, and novel or high-risk import matters are escalated to Regulatory Affairs leadership, Trade Compliance, Legal, or other appropriate subject matter experts.'
#LI-AD1
The pay range for this position at commencement of employment is expected to be between $65,700- $85,000, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
At Ingenyx, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.
Ingenyx is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Nearest Major Market: Worcester
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Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Medical Devices
- Consulting & Professional Services
- Insurance
- Banking & Financial Services
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 Pace Analytical Services, Parexel, and IQVIA, per current remote listings on Migrate Mate as of September 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, Medical Devices, and Consulting & Professional Services, based on current remote listings on Migrate Mate as of September 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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Find roles that match your experience and apply in just a few clicks.
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