INGENYX - Regulatory Affairs Specialist

Expected Travel : Up to 10% Requisition ID : 14562

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

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