Global Regulatory Affairs Specialist: Labeling, UDI & Data

Teleflex; Boston (MA); On-site; USD 85,000 - 125,000; Full time

Job summary

Ingenyx in Boston, MA is seeking a Regulatory Affairs Specialist to drive global regulatory activities for medical devices, focusing on labeling, UDI, and regulatory data. The role collaborates with Regulatory Affairs, Quality, Engineering, Operations, and Supply Chain to ensure ongoing compliance throughout the product lifecycle.

Candidates should have a Bachelor's in a related field and 2–5 years of regulatory experience, with knowledge of FDA GUDID/EUDAMED, registrations, and submissions.

Qualifications

• Bachelor’s degree or equivalent in regulatory affairs or life sciences.
• 2–5 years of regulatory affairs or medical device experience.
• Experience with labeling, UDI, and regulatory submissions preferred.

Responsibilities

• Create, revise, review, and maintain medical device labeling and UDI data.
• Support global regulatory submissions, registrations, and market maintenance.
• Monitor regulatory changes and assess impact on products.
• Maintain regulatory registrations and certifications.

Job description

Ingenyx in Boston, MA is seeking a Regulatory Affairs Specialist to drive global regulatory activities for medical devices, focusing on labeling, UDI, and regulatory data. The role collaborates with Regulatory Affairs, Quality, Engineering, Operations, and Supply Chain to ensure ongoing compliance throughout the product lifecycle.

Candidates should have a Bachelor's in a related field and 2–5 years of regulatory experience, with knowledge of FDA GUDID/EUDAMED, registrations, and submissions.