Remote Regulatory Affairs Lead Jobs
Remote Regulatory Affairs Lead jobs are open across the U.S. at remote-first firms and distributed teams in life sciences, pharmaceuticals, medical devices, and biotech. 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 Lead 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 lead jobs.
- Bachelor's degree or higher in life sciences, pharmacy, chemistry, or a related field
- Five or more years of experience managing regulatory submissions to FDA or comparable agencies
- Hands-on experience authoring or coordinating IND, NDA, BLA, 510(k), or PMA submissions
- Proficiency with electronic submission systems such as eCTD publishing tools or Veeva Vault RIM
- Regulatory Affairs Certification (RAC) from RAPS preferred or required by many employers
- Strong cross-functional communication skills for working with clinical, quality, and legal teams
Tips for Your Remote Regulatory Affairs Lead Job Search
Signal remote readiness in your application
Remote regulatory affairs lead employers look for evidence that you can own submissions and agency timelines without daily check-ins. Call out specific tools you use for remote coordination, such as Veeva Vault, MasterControl, or SharePoint, and note any fully remote submission cycles you have led.
Apply early to remote roles that fit
Migrate Mate lists remote regulatory affairs lead openings from across the U.S. in one place, so you can find roles that match your regulatory background and apply directly without sorting through unrelated postings.
Show written communication as a core skill
Remote regulatory affairs leads write the majority of their stakeholder communication. Revise your cover letter and resume to showcase agency correspondence, response-to-deficiency letters, or internal regulatory briefings you have authored, because remote hiring managers weight written output heavily.
Target companies with distributed regulatory teams
Remote-first biotech companies and global CROs with established distributed teams have built the workflows and tools to onboard regulatory leads remotely. Focusing your search on companies that already operate this way reduces ramp-up friction and puts you in a more structured remote environment from day one.
Remote Regulatory Affairs Lead Jobs: Frequently Asked Questions
How do I get a remote regulatory affairs lead job?
Remote regulatory affairs lead roles go to candidates who can demonstrate strong written communication, self-directed project management, and the ability to move submissions and agency correspondence forward without in-person oversight. Companies hiring remotely screen for experience with eCTD publishing tools, regulatory information management systems, and cross-functional coordination in asynchronous environments. Candidates who document specific submission wins and timeline ownership in their application materials stand out.
Which companies hire remote regulatory affairs leads?
Employers currently hiring remote regulatory affairs leads include Pace Analytical Services, Parexel, and IQVIA, per current remote listings on Migrate Mate as of September 2026. Remote regulatory affairs lead roles are concentrated at remote-first biotech and med-device companies, distributed CRO and regulatory consulting firms, and global pharmaceutical companies that operate across time zones.
Can you get a remote regulatory affairs lead job with no experience?
Yes, but remote entry-level regulatory affairs lead positions are limited because independent work is expected from day one without office mentorship. Your best path is through smaller biotech startups or regulatory consulting firms that hire junior leads on distributed teams. A regulatory affairs certification, demonstrated knowledge of FDA or EMA submission processes, and a portfolio showing any regulatory documentation work can open doors in place of direct experience.
Do you need a degree for remote regulatory affairs lead jobs?
Usually, but the field matters as much as the credential itself. Most remote employers expect a degree in a life science, pharmacy, or engineering discipline, though regulatory affairs certifications and a strong submission history can carry significant weight. Candidates who show hands-on experience with IND, NDA, 510(k), or CE Mark submissions often advance past candidates with degrees but limited practical output.
Which industries hire the most remote regulatory affairs leads?
Most remote regulatory affairs lead openings sit in Biotechnology & Pharmaceuticals, Medical Devices, and Consulting & Professional Services, per current remote listings on Migrate Mate as of September 2026. These sectors hire regulatory affairs leads remotely because product development, submissions, and agency interactions are largely document-driven and can be coordinated effectively across distributed teams.
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