Global Regulatory & Labeling 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

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