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Teleflex

Regulatory Affairs Specialist

Teleflex

. Create, revise, review, and maintain medical device labeling, including product and packaging labels, IFUs, symbols, regulatory statements, and other controlled labeling.

Posted 10/16/2026full-timeRemote • Massachusetts • United StatesMid-LevelSenior💰 $87,400 - $131,100 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in medical device labeling, regulatory submissions, and UDI management, ensuring compliance with FDA GUDID, EU EUDAMED, and global regulatory standards. Strong organizational and analytical skills are essential for managing cross-functional collaboration and maintaining accurate regulatory product data.

Highest-signal resume keywords
Medical Device LabelingRegulatory SubmissionsUDI ManagementFDA GUDIDEU EUDAMED

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
Regulatory AffairsLabeling ExperienceChange AssessmentsProduct Maintenance ActivitiesRegulatory DatabasesDocument Management SystemsERP SystemsAnalytical ThinkingAttention to DetailData Management
Soft Skills
OrganizationWritten CommunicationVerbal CommunicationCross-Functional CollaborationPriority Management
Tools & Technologies
Labeling/Artwork SystemsRegulatory DatabasesDocument Management SystemsERP Systems
Industry Keywords
Medical Device Regulatory RequirementsGTINsGLNsGDSNUDIRegulatory ComplianceNotified BodiesAuditsInspectionsMarket Maintenance

Tech Stack

Tools & technologies
ERP

About the role

Key responsibilities & impact
  • Create, revise, review, and maintain medical device labeling, including product and packaging labels, IFUs, symbols, regulatory statements, and other controlled labeling.
  • Coordinate labeling changes and approvals with Regulatory Affairs, Quality, Engineering, Operations, and other stakeholders.
  • Ensure labeling aligns with approved registrations, product requirements, regulations, and company standards.
  • Support UDI assignment and maintenance, including GTINs, Basic UDI-DI, UDI-DI, UDI-PI, and applicable device identifiers and product data attributes.
  • Maintain UDI and regulatory product information in FDA GUDID, EU EUDAMED, and applicable regional registries.
  • Support GS1 Global Healthcare, GS1 Member Organizations, GLNs, GTINs, GDSN, and applicable data-pool requirements.
  • Monitor changing labeling, UDI, product identification, data attribute, and regulatory database requirements; support gap and impact assessments.
  • Implement approved labeling, data, system, and process changes.
  • Maintain alignment between approved labeling, product master data, UDI databases, GS1/GDSN data, health authority databases, and commercial trading partner information.
  • Maintain accurate regulatory product data and records in applicable systems.
  • Support system and data changes; coordinate system issues and vendor support with IT and external providers.
  • Support system implementations, migrations, testing, and validation.
  • Support global regulatory submissions, registrations, renewals, notifications, and market maintenance.
  • Assess product, manufacturing, and business changes for regulatory impact.
  • Maintain regulatory registrations, certificates, approvals, and supporting documentation.
  • Support regulatory authorities, Notified Bodies, audits, inspections, and other regulatory requests.
  • Support regulatory activities for new products, market expansions, manufacturing transfers, and legal entity changes.
  • Collaborate with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, Commercial, IT, and other functions throughout the product lifecycle.

Requirements

What you’ll need
  • Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field; equivalent relevant experience may be considered.
  • 2–5 years of Regulatory Affairs or related medical device experience preferred.
  • Working knowledge of medical device regulatory requirements in the U.S. and/or international markets.
  • Experience supporting regulatory submissions, registrations, change assessments, or product maintenance activities preferred.
  • Experience with medical device labeling and UDI strongly preferred.
  • Familiarity with FDA GUDID, EU EUDAMED, GS1, GTINs, GLNs, and/or GDSN preferred.
  • Experience with regulatory databases, document management systems, ERP systems, or labeling/artwork systems is beneficial.
  • Strong attention to detail, organization, analytical thinking, and written and verbal communication skills.
  • Ability to manage multiple priorities and work effectively with global, cross-functional teams.
  • Labeling experience, regulatory awareness, eIFU management knowledge, and strong data and systems skills.
  • Expected travel of up to 10%.

Benefits

Comp & perks
  • Medical insurance
  • Prescription drug insurance
  • Dental insurance
  • Vision insurance
  • Flexible spending accounts
  • Participation in 401(k) savings plan
  • Paid time off (PTO)
  • Short-term disability
  • Long-term disability
  • Parental leave