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Senior Regulatory Compliance Engineer

26 MAR '23: For an eye-care company that takes precision to a whole new level, we’re looking for a Regulatory Compliance Engineer. They’re committed to helping people around the world see better every day. Through scientific and technological innovation, operational excellence and close working relationships with their eye care professional customers, they have helped improve the vision of millions and become a trusted global leader in the contact lens industry.

Details

Medical Devices

Engineering

Eerbeek - Netherlands

40 hours per week

About your role

This is how you will make the difference

As a Regulatory Compliance Engineer you will identify, evaluate, and ensure meaningful compliance with all applicable regulatory laws and regulations. The successful candidate will be responsible for conducting reviews of all and all furniture target markets to ensure knowledge and fulfilment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, installation, and support in all chosen distribution markets.

what's needed

What you bring

A good candidate has a bachelor in an Engineering or Science discipline or equivalent combination of education and experience. Furthermore, you are able to:

Remain aware of new or updated regulations, laws, standards, and other official enactments relevant to the company;
Provide detailed analysis, official recommendations, and gap analyses for new or revised enactments;
Submit medical device adverse and field corrective actions reports and recall notifications;
Ensure adequate compliance schemes associated with all regulatory compliance systems, as required by law;
Author and coordinate all regulatory product clearance submissions;
Knowledge of Medical Devices related regulations MDD and MDR;
Experience in product registration EU and Asia.

What we offer

What's in it for you

This organisation offers you:

A competitive salary and comprehensive benefits package;
An excellent pension scheme;
The opportunity to create high-quality products and services for the organisation's customers.

Join the organisation and be a part of a team that values innovation, collaboration, and excellence.

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This is how you will make the difference

What you bring

What's in it for you

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