Regulatory Specialist

1 month ago


Cheshire, United Kingdom Adecco Full time

Regulatory Specialists, I have a hybrid role for you, requiring 2 out of 5 days on site, the rest from the comfort of your home
Adecco are pleased to be working with a global Medical Device manufacturer, looking to hire a Regulatory Specialist to join their pre-market team on a permanent basis.

This role will see you work with a small, but lively team, where collaboration and teamwork is celebrated.
You will work on supporting new product developments by creating technical documentation for submissions into Europe and the US.

The role is a key role within the business, interfacing with multiple business units including R&D, Regulatory Affairs, Clinical, Quality, Engineering, Manufacturing, Sales, and Marketing.

**Key responsibilities**:

- Compile and submit regulatory-compliant documentation for all product classifications in Europe and USA to ensure pre-market approvals are achieved in a timely manner.
- Responsible for regulatory review and approval of key compliance records e.g. design control documentation, labelling, marketing literature, and change controls.
- Generate product labelling requirements
- Support Risk Management System activities

To be considered for this role experience with technical file creation is essential, alongside an appreciation of MDR, having worked with the EU market.

The team have a great mix of senior specialists and more junior, and with development plans in place, there won't be a lack of opportunity for you to continue your professional growth.


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