Quality Regulatory Manager

2 weeks ago


Cambridge, United Kingdom Adecco Full time

Adecco is lucky to be working with a unique and innovative Medical Device business looking to hire a Quality Regulatory Manager for the team.

The business is a start-up company spun out of Cambridge University 5 years ago. With strong financials and several awards already under their belt, this is a business who are well recognised and going places

Entering the business as a Quality Regulatory Manager, you would be the sole person responsible for the Quality Management Systems and lead the market entry of the product.

The company already has an established QMS compliant with ISO13485, so your job will be to maintain the system and make improvements as the company continues to grow alongside helping the business to achieve its UKCA mark and FDA 510(k).

To be considered for this role it is essential you have:

- 5 years + of experience working in a Medical Device environment
- Worked to maintain audit schedules and be the point of contact for internal and supplier audits
- Experience working with the FDA and entering products into the US market
Offering flexible working hours and a hybrid model of working, the client is looking for someone who will thrive in a dynamic start-up environment.


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