Regulatory Manager

2 weeks ago

Cambridge, United Kingdom SciPro Full time

**Regulatory Manager UK - Medical technology - £65k - £85k**

SciPro are currently partnering with an innovative start-up medical technology business for the recruitment of an experienced Regulatory Manager to join their team in the UK. The company are focused developing Machine Learning and Artificial Intelligencemethods to aid the diagnosis of cancer precisely while being easily accessible, cost-effective and quick.

The organization have their own unique and complex AI and Machine learning based software, designed to report the presence of prostate cancer to improve patient diagnosis. This offers an amazing opportunity to join a company with incredible prospects forits employees while being a part of a very impactful industry.

This is a great opportunity for an experienced Regulatory Manager to lead the development and continuous improvement of the quality management system and maintain UKCA and FDA regulatory approvals.

This role will include:

- Handling Regulatory Affairs to obtain and maintain clearances in new markets.
- Handling Complaints and providing guidance in terms of improvements to products following analysis of reported issues.
- Supervising the management of risk management, cybersecurity, data privacy and usability compliance activities.

Ideal Requirements:

- University Degree specifically one in biomedical sciences, biomedical engineering or similar healthcare-related disciplines.
- Minimum of 4 years' experience developing quality systems and technical files/ technical documentation for Class II or Class III regulated medical devices, Including QMS, ISO 13485, ISO 14971, ISO 62304, CE marking, MDR and FDA 510k
- Minimum 2 years' experience of software as a medical device.

Why Apply:

- Competitive Salary.
- Opportunity to advance in a growing business.
- Work in an environment that provides a real impact to the cancer research industry.

**If you are interested in this opportunity, please click apply

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