Quality and Regulatory Manager - St Ives, Cambridgeshire, UK

Sector: In-vitro Diagnostics. Medical Devices
Start: Immediate
Salary: Competitive, depends on experience - +pension +bonus +share options

Sense is a start-up in-vitro diagnostics company based in Cambridge and Oxford UK. The company is developing a new class of molecular diagnostic test device for a range of clinical applications. Founded by an experienced and highly successful leadership team, Sense has ambitious plans to grow from its strong foundations and become a leader in the field. The company has significant backing from leading venture capitalist investors and is currently industrialising its first commercial products.

This is a full-time role based at the company’s Cambridge facility to work directly alongside the Chief Development Officer as the company takes its first product through industrialisation and clinical trials. The role can be structured to suit the right candidate but is likely to include:

• Helping to define and populate the company’s quality procedures in line with both ISO13485 and 21 CFR part 820 alongside our internal team and external quality and regulatory consultants.
• Research and input to key technical documents including analysis of relevant standards, creation and review of product specifications, verification and validation plans etc
• Supporting and carrying out risk management activities in line with ISO14971
• Supporting the setup of internal facilities and capabilities from a quality and regulatory standpoint
• Administering the company’s electronic QMS (Greenlight Guru) to ensure it is properly maintained and populated
• Act as the company’s internal consultant on quality and regulatory matters to support the design and development teams with guidance relating to quality and regulatory documentation
• Liase with external suppliers, contract manufacturing partners and corporate partners on issues relating to quality and regulatory affairs

It is intended that as the company grows the quality and regulatory affairs team will grow under the management of the preferred candidate but in the immediate term it is expected the candidate will be able to fulfil a number of roles as is typical in small company environments.

Ideal Candidate
The ideal candidate for this role will have significant experience in the field of product development and manufacture of IVDs, ideally in the field of molecular diagnostics. They will be familiar with all relevant regulations including both European and US requirements and comfortable researching and becoming expert in any associated areas they do not immediately have in depth knowledge of. Other medical or drug delivery device experience may also be considered provided the candidate has an appropriate background of new product development. The candidate will be highly proactive and hands-on and comfortable in taking ownership of both the creation of and population of documents with the QMS to a very high standard. The preferred candidate will be excited by the prospect of building the company alongside realising it’s first product and driven by achieving success through

Personal Attributes
The candidate should ideally have the following personal attributes:
• Calm under pressure
• Motivated to make a difference
• High standard of written English and communication skills
• Excellent attention to detail
• Flexibility to adapt to a fast-moving environment

Application Instructions: 

Please send a CV with covering letter outlining your suitability for this role via email to careers@sense-bio.com. Applicants must have the right to work in the UK. Applicants from recruitment consultants are not accepted. We will only contact candidates who are selected for interview.

Application Closing Date: 
18 January