INGENYX - Regulatory Affairs Specialist

Teleflex•Templeton, MA

8d•$87,400 - $131,100

About The Position

Ingenyx is seeking a Regulatory Affairs Specialist to support global regulatory activities for medical devices, with a focus on product labeling, Unique Device Identification (UDI), and regulatory product data. The Specialist will support product registrations and regulatory maintenance, assess and implement regulatory changes, maintain compliant labeling and regulatory data, and assist with submissions and documentation for products in global markets. The role works across Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, Commercial, and other functions to support product compliance throughout the product lifecycle. Responsibilities include creating, reviewing, revising, and maintaining medical device labeling; coordinating labeling changes and approvals; supporting UDI assignment and maintenance; maintaining UDI and regulatory product information in health authority databases and applicable data systems; and keeping information aligned across approved labeling, product master data, databases, and commercial trading partner information. The Specialist will also maintain regulatory product data and records, coordinate system issues, and support system implementations, migrations, testing, and validation. The role supports global regulatory submissions, registrations, renewals, notifications, and market maintenance; monitors regulatory requirements; assesses product, manufacturing, and business changes for regulatory impact; maintains registrations, certificates, approvals, and supporting documentation; and assists with audits, inspections, and other regulatory requests. The position also supports regulatory activities for new products, market expansions, manufacturing transfers, and legal entity changes. A bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field is required, although equivalent relevant experience may be considered. Two to five years of Regulatory Affairs or related medical device experience is preferred. The position's expected pay range at commencement is $87,400–$131,100, depending on factors including market location and job-related knowledge, skills, and experience. Benefits include medical, prescription drug, dental, and vision insurance; flexible spending accounts; participation in a 401(k) savings plan; and paid time off benefits such as PTO, short- and long-term disability, and parental leave, subject to the position offered.

Requirements

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field; equivalent relevant experience may be considered.
Working knowledge of medical device regulatory requirements in the U.S. and/or international markets.
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.
Ability to manage day-to-day labeling and UDI activities, maintain accurate regulatory product information, and coordinate changes across multiple systems.

Nice To Haves

Two to five years of Regulatory Affairs or related medical device experience.
Experience supporting regulatory submissions, registrations, change assessments, or product maintenance activities.
Experience with medical device labeling and UDI.
Familiarity with FDA GUDID, EU EUDAMED, GS1, GTINs, GLNs, and/or GDSN.
Experience with regulatory databases, document management systems, ERP systems, or labeling/artwork systems.
Labeling experience, regulatory awareness, eIFU management knowledge, and strong data and systems skills.

Responsibilities

Create, revise, review, and maintain medical device 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, applicable regulations, and company standards.
Support UDI assignment and maintenance, including GTINs, Basic UDI-DI, UDI-DI, UDI-PI, device identifiers, and product data attributes.
Maintain UDI and regulatory product information in applicable health authority databases, including FDA GUDID, EU EUDAMED, and 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, and support gap and impact assessments.
Implement approved labeling, data, system, and process changes arising from regulatory and commercial requirements.
Help maintain alignment among 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 within applicable systems.
Support system and data changes resulting from regulatory, labeling, UDI, and commercial requirements.
Coordinate system issues and vendor support with IT and external service providers as needed.
Support system implementations, migrations, testing, and validation activities as applicable.
Support global regulatory submissions, registrations, renewals, notifications, and market maintenance activities.
Monitor regulatory requirements and support gap and impact assessments.
Assess product, manufacturing, and business changes for potential 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.