Regulatory Specialist

Join a Pioneering MedTech Company as a Regulatory Specialist! - Apply Now!

Title: Regulatory Specialist

Reporting To: Director of Regulatory Affairs

Location: Copenhagen, Denmark

Industry: Life Sciences - Medical Devices

Salary: upto 55,000DKK/month

At Darwin Recruitment, we are thrilled to be partnered with a leading medical device/technology company who are revolutionizing the care industry. They are working together to improve patient lives with their diagnostics tools, that are helping to cure some of the largest global health challenges.

Position Overview:

As a regulatory Specialist, you will work within the Regulatory and Quality team reporting into the Director of RA. You will be responsible for delivering the regulatory life cycle management. You will have the opportunity to work with a wide range of products with regulatory and technical complexity.

Your Responsibilities:

• Provide regulatory and technical input or guidance
• Working within multiple projects at the same time
• Evlauting proposed preclinical, clinical and manufacturing changes for regulatory filing solutions
• Working with RA change assessment of impact for in-vitro diagnostics and medical devices
• Translate and implement regulatory knowledge
• Submission and follow-up of registration documentation to local regulatory authorities.
• Ensure full compliance with legal requirements and internal procedures

Your Qualifications:

• Ideally have a masters degree in Engineering, Pharmacy, Biology, Biochemistry or the equivalent
• 5 years of experience within a RA function
• Compliance with regulatory experience
• Detailed knowledge of regulatory requirements for medical devices

Don't miss this remarkable opportunity to contribute to the growth of a medtech company. Join us today!

Please apply or email james.allen@darwinrecruitment for more information.

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

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