Regulatory Specialist
2 months ago
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.
Working in a small team, this role will focus 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 position offers a hybrid working style, with only two days per week required onsite.
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