INGENYX - Regulatory Affairs Specialist

Teleflex; Milton (MA); On-site; USD 90,000 - 130,000; Full time

Job summary

Ingenyx is seeking a Regulatory Affairs Specialist to support global regulatory activities for medical devices, focusing on product labeling, UDI, and regulatory product data. You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, and Supply Chain to create, revise, and maintain labeling, assign and maintain UDI data, and keep health authority databases up to date.

Bachelor's degree in Regulatory Affairs or a related field with 2–5 years of regulatory experience is

Qualifications

• Working knowledge of medical device regulatory requirements in the U.S. and international markets.
• Experience supporting regulatory submissions, registrations, change assessments, or product maintenance activities.
• Experience with medical device labeling and UDI strongly preferred.
• Experience working with regulatory databases, document management systems, ERP systems, or labeling/artwork systems is beneficial.

Responsibilities

• Create, revise, review, and maintain medical device labeling, including product and packaging labels, IFU, 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.
• 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.

Skills

Regulatory knowledge

Regulatory submissions

Labeling & UDI

Documentation management

Education

Bachelor's degree in Regulatory Affairs/Life Sciences/Engineering/Quality

Tools

Regulatory databases

Document management systems

ERP systems

Labeling/artwork systems

Job description

Expected Travel : Up to 10% Requisition ID : 14562

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. specialty sutures, braids and fibers; Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

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.

Create, revise, review, and maintain medical device labeling, including product and packaging labels, IFU, 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.
• 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.

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or a related field; 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.
• Experience working with regulatory databases, document management systems, ERP systems, or labeling/artwork systems is beneficial.
• 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 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. 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.

#We do not ask for money or require equipment purchase up-front.

Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status.