Remote Regulatory Affairs Specialist Jobs
Remote regulatory affairs specialist jobs are open across the U.S. in pharmaceutical, biotech, medical device, and consumer products companies, from entry-level regulatory coordinators to senior directors managing global submissions on distributed teams. Employers hiring remotely right now include Pace Analytical Services, Parexel, and IQVIA. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 94+ Remote Regulatory Affairs Specialist 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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Find JobsRemote Regulatory Affairs Specialist Job Market
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 specialist jobs.
- Bachelor's degree in life sciences, chemistry, engineering, or a related field
- Experience preparing and submitting regulatory filings such as 510(k), PMA, NDA, or BLA
- Knowledge of FDA regulations including 21 CFR parts relevant to the product type
- Proficiency with regulatory information management systems such as Veeva Vault or RIMS
- Regulatory Affairs Certification (RAC) from RAPS preferred for senior roles
- Strong technical writing skills for preparing regulatory summaries, briefing documents, and SOPs
Tips for Your Remote Regulatory Affairs Specialist Job Search
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs specialist openings from across the U.S. in one place, so you can find roles that match your background and apply directly. Remote postings attract high applicant volume fast, so applying within the first few days of a listing matters.
Show async communication skills upfront
Remote regulatory affairs employers prioritize candidates who can communicate precisely in writing without real-time back-and-forth. In your cover letter and resume, highlight experience writing submission summaries, SOPs, or regulatory correspondence that others acted on without clarifying calls.
Demonstrate fluency with remote regulatory tools
Call out your hands-on experience with document management and submission platforms like Veeva Vault, MasterControl, or eCTD publishing tools. Remote teams cannot afford onboarding time for software basics, so naming specific platforms signals you can contribute from day one.
Target companies with established distributed teams
Remote regulatory affairs roles are most stable at companies that already run distributed regulatory or clinical teams, not those testing remote work for the first time. Look for job descriptions that reference cross-functional remote collaboration, multiple time zones, or global regulatory strategy.
Remote Regulatory Affairs Specialist Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs specialist job?
Remote regulatory affairs specialist roles go to candidates who can demonstrate self-direction, precise written communication, and fluency with document management systems like Veeva Vault or MasterControl. Remote employers screen heavily for async collaboration skills, comfort with cross-functional digital workflows, and the ability to manage submissions and timelines without in-person oversight. Certifications like RAC from RAPS give your application a concrete edge over generalist candidates.
Which companies hire remote regulatory affairs specialists?
Companies hiring remote regulatory affairs specialists right now include Pace Analytical Services, Parexel, and IQVIA, based on current remote listings on Migrate Mate as of September 2026. Remote regulatory affairs roles concentrate at pharmaceutical companies, medical device manufacturers, biotech firms, and contract research organizations that operate distributed regulatory teams across multiple markets.
Can you get a remote regulatory affairs specialist 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 with minimal supervision. Your strongest entry points are contract research organizations and startups that hire junior regulatory coordinators remotely. In place of experience, show familiarity with FDA submission processes, regulatory databases, and document control tools, and highlight any coursework, internships, or independent projects involving compliance or technical writing.
Do you need a degree for remote regulatory affairs specialist jobs?
Usually, but the field is more credential-flexible than many assume. Most remote employers prefer a bachelor's in a life sciences, chemistry, or engineering discipline, but candidates who hold RAC certification and can show hands-on submission experience, strong technical writing, and working knowledge of FDA or international regulatory frameworks are competitive even without a traditional degree path.
Which industries hire the most remote regulatory affairs specialists?
The sectors hiring the most remote regulatory affairs specialists are Biotechnology & Pharmaceuticals, Medical Devices, and Consulting & Professional Services, based on current remote listings on Migrate Mate as of September 2026. These industries hire regulatory affairs specialists remotely because their submission, compliance, and labeling work is documentation-driven and integrates naturally into distributed team structures across time zones.
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