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Reference: JOB502249
Location: Humlebæk, Denmark
Employer: Coloplast A/S
Application deadline: CLOSED
Regulatory Affairs Manager in Global Operations
Coloplast A/S, Humlebæk
Regulatory Affairs & Product Support department in Global Operations is looking for a Regulatory Affairs (RA) Manager for a permanent position.
In this position you will communicate regulatory requirements for medical devices in cross-functional projects to ensure that documentation continuously is in compliance, and your key responsibilities will be
Communicate worldwide regulatory requirements and regulations for medical devices effectively within the company. Participate in cross functional projects for product modification, and ensuring regulatory compliance; incl. review and approval of relevant documentation. Coordinate and compile high quality regulatory files for worldwide submissions. Maintain all appropriate records as direct evolution of design changes and process changes, submission of amendments, supplements or new applications to authorities as required.Coloplast A/S, 18.?maj