Regulatory Submissions Lead – Medical Devices (US/EU)

Intepros; Lafayette (CO); On-site; USD 110,000 - 170,000; Full time

Job summary

Intepros is seeking a Sr Regulatory Affairs Specialist to drive regulatory submissions for medical devices in the US and EU. You will coordinate document packages with cross-functional teams and ensure compliance across design, manufacturing and labeling.

This role requires strong knowledge of FDA and EU MDR processes and interaction with Notified Bodies. Responsibilities include preparing submissions, supporting audits and renewals, and guiding labeling and protocol changes to maintain

Qualifications

• University Degree required; advanced degree preferred.
• Minimum 4 years of relevant regulatory experience, or 2 years with advanced degree.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions across the company.
• Support internal audits and inspections.
• Lead or compile materials for submissions, license renewals and annual registrations.
• Recommend labeling, manufacturing, marketing changes for regulatory compliance.
• Monitor regulatory procedures and engage with agencies as needed.

Skills

Regulatory affairs

Medical devices

FDA regulations

EU MDR

Change control

Project coordination

Documentation

Education

University Degree

Advanced degree

Job description

Intepros is seeking a Sr Regulatory Affairs Specialist to drive regulatory submissions for medical devices in the US and EU. You will coordinate document packages with cross-functional teams and ensure compliance across design, manufacturing and labeling.

This role requires strong knowledge of FDA and EU MDR processes and interaction with Notified Bodies. Responsibilities include preparing submissions, supporting audits and renewals, and guiding labeling and protocol changes to maintain