Regulatory Affairs Specialist - IVD

Oct 05, 2020
Nov 04, 2020
Karina Aleksandraviciute
Jobseeker Type
Organization Type
Contract Type
Full Time

My client provides life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise.

I am currently looking for an experienced Regulatory Affairs Specialist.

This is your opportunity to join a dynamic, versatile and growing team, where you will play a key role in supporting and driving development projects and obtaining regulatory approvals for new devices. It is also an opportunity to work with IVD products of many different regulatory classifications, and including both hardware, software and immunochemistry technologies.

Develop and implement programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations.

Serve as the regulatory representative for new product introduction and new product improvement projects for all product types; participate in team meetings and coordinate quality activities as required

Prepare document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies.

To be qualified for this role you need to have at least 5 years in a similar position within MD/IVD.

If you or someone you know is open to a new opportunity - please do not hesitate to contact me for more information via

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