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 Pace Analytical Services, Parexel, and IQVIA. See the openings below and apply to the ones that match your experience.
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Showing 5 of 94+ Remote Regulatory Affairs Manager 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 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 Pace Analytical Services, Parexel, and IQVIA and others right now, based on current remote listings on Migrate Mate as of September 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, Medical Devices, and Consulting & Professional Services, per current remote listings on Migrate Mate as of September 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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