Regulatory Affairs Specialist — Labeling & UDI

Teleflex; Oklahoma City (OK); On-site; USD 87,000 - 109,000; Full time

Benefits offered by this job

Medical, prescription drug, dental, & 

Vision insurance

401(k) savings plan

Job summary

Ingenyx seeks a Regulatory Affairs Specialist to support global regulatory activities for medical devices, focusing on labeling, UDI, and regulatory data.

You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, and other teams to ensure compliant product labeling and timely registrations.

The role requires knowledge of FDA GUDID, EU EUDAMED, and data systems, with a track record in submissions and maintenance of regulatory data.

Qualifications

• 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.

Responsibilities

• 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 expertise

Attention to detail

Written & verbal communication

Cross-functional collaboration

FDA/GUDID knowledge

Education

Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, Quality, or related field

Tools

FDA/UDID databases

GDSN/GS1 data

ERP systems

Labeling systems

Job description

Ingenyx seeks a Regulatory Affairs Specialist to support global regulatory activities for medical devices, focusing on labeling, UDI, and regulatory data.

You will collaborate with Regulatory Affairs, Quality, Engineering, Operations, and other teams to ensure compliant product labeling and timely registrations.

The role requires knowledge of FDA GUDID, EU EUDAMED, and data systems, with a track record in submissions and maintenance of regulatory data.