INGENYX - Regulatory Affairs Specialist

Position Summary

We are seeking a Regulatory Affairs Specialist to support global regulatory activities for medical devices, with specific responsibilities for product labeling, Unique Device Identification (UDI), and regulatory product data.
This role will support product registrations and regulatory maintenance activities, assess and implement regulatory changes, maintain compliant labeling and regulatory data, and assist with submissions and documentation required to support products in global markets.

The Specialist will work closely with Regulatory Affairs, Quality, Engineering, Operations, Supply Chain, Commercial, and other functions to support ongoing product compliance throughout the product lifecycle.

Principal Responsibilities

Labeling & UDI
•    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 applicable stakeholders.
•    Ensure labeling remains aligned with approved registrations, product requirements, applicable 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 within applicable health authority databases, including FDA GUDID, EU EUDAMED, and applicable regional registries.
•    Support activities associated with GS1 Global Healthcare, GS1 Member Organizations, GLNs, GTINs, GDSN, and applicable data-pool requirements.
•    Monitor new and changing labeling, UDI, product identification, data attribute, and regulatory database requirements and support Regulatory Affairs with gap and impact assessments.
•    Implement approved labeling, data, system, and process changes resulting from new or revised regulatory and commercial requirements.
•    Help maintain alignment between approved labeling, product master data, UDI databases, GS1/GDSN data, health authority databases, and commercial trading partner information.

Regulatory Systems & Data
•    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.

Regulatory Affairs
•    Support global regulatory submissions, registrations, renewals, notifications, and market maintenance activities.
•    Monitor changing 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.

Education / Experience Requirements

•    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 working 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.

Specialized Skills / Other Requirements

The successful candidate will combine labeling experience, regulatory awareness, eIFU management knowledge, and strong data and systems skills.
This role requires a detail-oriented individual who can effectively manage day-to-day labeling and UDI activities, maintain accurate regulatory product information, coordinate changes across multiple systems, and work collaboratively with Regulatory Affairs, Quality, IT, and other functions to support ongoing compliance.

The pay range for this position at the commencement of employment is expected to be between $87,400.00 and $131,100.00; however, the 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, the 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.

#LI-AD1