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Regulatory Affairs Specialist at Medtronic - ApplyBlast

Regulatory Affairs Specialist

Medtronic

4 months ago

3.7 on Glassdoor

Copenhagen, Denmark

Hybrid

Full Time

Junior

0 applicants

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About this role

Regulatory Affairs Specialist at Medtronic drives quality and regulatory compliance for medical devices across the Nordic countries. The role involves assisting sales teams, managing post-market surveillance, and ensuring alignment with local legislation and ISO standards.

Responsibilities

Monitor and interpret Nordic regulatory requirements for medical devices
Coordinate and support Field Safety Corrective Actions with sales teams
Manage inquiries from competent authorities and maintain regulatory records
Provide guidance to sales teams on product complaint handling and returns
Support Quality Management System activities including supplier and distributor management