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 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 Associate 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 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 Pace Analytical Services, Parexel, and IQVIA and others right now, based on current remote listings on Migrate Mate as of September 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, Medical Devices, and Consulting & Professional Services, based on current remote listings on Migrate Mate as of September 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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