Organisation: Sense Biodetection Limited Location: St Ives, Cambridgeshire, UK
Job Title: Quality and Regulatory Manager Sector: In-vitro Diagnostics.
Medical Devices Start: Immediate Salary: Competitive, depends on experience - +pension +bonus +share options
Company 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.
Role 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 postholder will:
• Understand and have oversight of In Vitro Diagnostics within the Quality systems
• Develop and maintain a compliant Quality Management system that is ‘fit for purpose’ and adapts to changing business needs.
• Have awareness of Regulation (EU) 2017/746
• Helping to define and populate the company’s quality procedures in line with both ISO 13485 and 21 CFR part 820 alongside our internal team and external quality and regulatory consultants and ensure those processes needed for the electronic quality management system (eQMS) are established, implemented and maintained.
• Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to standards, practices and regulations
• Research and input to key technical documents including analysis of relevant standards, creation and review of product specifications, verification and validation plans etc • Report to senior management through management review on the performance of the quality management system and any need for improvement using KPIs
• Perform and executes audits in compliance with ISO 13485, CFR 820.0 and IVDR as applicable
• Management of the internal audit program.
• Supporting and carrying out risk management activities in line with ISO 14971
• Supporting the setup of internal facilities and capabilities from a quality and regulatory standpoint
• Provide Quality and Regulatory expertise to product development core teams to support the design and development teams with guidance relating to compliance activities
• Liaise 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.
Job Specification – Quality Manager
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. They will have the ability to gather, analyse and interpret quality information and changes in the quality environment using the appropriate quality tools. 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 eQMS to a very high standard.
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 • Pragmatic team member and flexibility to work within the dynamics of a cross-functional team • Excellent communication skills • Able to get on with and influence people both internally and externally to achieve objectives • Able to work with minimum supervision and as a part of a team
To Apply: Please send a CV with covering letter outlining what you would hope to bring to this role via email to email@example.com. Applicants must have the right to work in the UK. We will only contact candidates who are selected for interview.