Regulatory Lead

2 weeks ago


Dudley, United Kingdom Adecco Full time

Adecco are working with a highly successful Medical Device manufacturer looking for a Regulatory Lead to join them on a permanent basis.

This role will see you as the sole person responsible for Regulatory Affairs, supported closely by the New Product Development and Quality teams.

With a variety of products across the business, this role would suit someone with the ability to manage projects concurrently.

Day to day will see you focus on:

- Guide and coordinate the compliance activity of new product development teams.
- Lead accreditation submissions: project manage the technical file creation, bio compatibility and clinical evaluation submissions and risk file management file creation.
- Managing the MDR transition
- Leading product submissions into the EU, US and Canada, whilst helping expand their reach into new markets
- Creating and maintaining technical documentation across the product portfolio

The company is flexible with its working style, ideally looking for site visits a few times per month.

To speak to a recruitment expert please contact Amy Holder


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