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Senior Regulatory Compliance Specialist

02 OCT ’23: This organisation is a leading global manufacturer of contact lenses. With a strong focus on research and development, the company strives to introduce groundbreaking products to enhance wearer experience. By leveraging cutting-edge manufacturing processes and collaborating with eye care professionals, they are a leader in contact lens innovation. This organisation is currently looking for a Senior Regulatory Compliance Specialist.

Details

Medical Devices

Medical Affairs

Eerbeek - Netherlands

40 hours per week

Get to know

Your consultant

Pieter Groenendal

+31 6 45 07 05 64 p.groenendal@qtcrecruitment.com

About your role

This is how you will make the difference

The Regulatory Compliance (RC) Engineer's role encompasses identifying, evaluating, and ensuring comprehensive adherence to applicable regulatory laws and regulations, establishing inherent compliance efforts within the company's Quality System. Additionally, the RC Engineer conducts thorough market reviews to ensure understanding and fulfilment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other necessary requirements to facilitate import, sales, distribution, installation, and support across selected markets.

what's needed

What you bring

We are looking for someone with 3-5 years of experience as an RC Specialist in the Medical Devices field
•   A Bachelor's degree in an Engineering or Science discipline or equivalent combination of education and experience;
•   Excellent knowledge of the English language (written and verbal), with Dutch language proficiency being advantageous;
•   Thorough understanding of Medical Device related regulations such as MDD and MDR;
•   Experience in product registration within the EU and Asia;
•   Proficiency in SOP, validation processes, and technical writing;

• Process oriented mindset.

What we offer

What's in it for you

This company offers an attractive salary and a comprehensive benefits package that includes a top-notch pension scheme. In addition, you will have the chance to contribute to the development of exceptional products and services. Join the team and become an integral part of an organisation that highly values innovation, collaboration, and a commitment to excellence.

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This is how you will make the difference

What you bring

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