Senior Med Device Regulatory Specialist

Intepros; Mansfield (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intepros is seeking a Sr Regulatory Affairs Specialist in Mansfield, MA to coordinate regulatory submissions and ensure continued compliance for medical devices. The role focuses on US FDA submissions (510(k), LTF) and EU MDR changes, including interactions with Notified Bodies and change notifications.

The candidate will lead document preparation, support labeling and manufacturing changes, and monitor regulatory tracking systems, engaging with regulatory agencies as needed.

Qualifications

• 3–5 years of regulatory affairs experience for medical devices.
• Experience with US FDA regulatory submissions (510k, LTF).
• Experience with EU MDR and Notified Bodies for change notifications.
• Experience with medical device manufacturing and design changes.
• University degree required; advanced degree a plus.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions.
• Lead or compile materials for submissions, license renewals and annual registrations.
• Recommend changes for labeling, manufacturing, and clinical protocols.
• Monitor and improve tracking and control systems for regulatory compliance.
• May interact with regulatory agencies and support early clinical trial approvals.

Skills

FDA/Regulatory

EU MDR

Change assessment

Regulatory submissions

Liaison with agencies

Education

Bachelor's degree in a scientific/engineering field

Job description

Intepros is seeking a Sr Regulatory Affairs Specialist in Mansfield, MA to coordinate regulatory submissions and ensure continued compliance for medical devices. The role focuses on US FDA submissions (510(k), LTF) and EU MDR changes, including interactions with Notified Bodies and change notifications.

The candidate will lead document preparation, support labeling and manufacturing changes, and monitor regulatory tracking systems, engaging with regulatory agencies as needed.