We are proud to be partnering with a fast growing, fast moving MedTech business specializing in the wider uro-oncology field. The company has built a strong and rapidly growing international business to become one of the leading providers of prostate cancer diagnosis and treatments.
They are looking for Quality and Regulatory professional with an enthusiasm for the industry and eagerness to help the business evolve to apply for the role of Quality and Regulatory Affairs Manager.
As the Quality and Regulatory Affairs Manager, you will oversee all aspects of the company's quality management system, current product regulatory compliance, and participate in medical device development projects contributing to the quality assurance and regulatory affairs deliverables as required.
The RA/QA Manager role will help the Management Team to:
- Prepare registration submissions for medical devices.
- Advise on compliance to current and forthcoming regulation.
- Ensure the company's QMS remains fit for purpose developing, implementing, and maintaining appropriate processes and procedures for the scope of activities relevant to the company's growth.
- Perform quality system assessments and/or audits for compliance to ISO 13485 and other regulations (e.g., EU MDR), both internally and externally.
- Ensure all appropriate technical documentation is developed, held on file and, where necessary, submitted for review and approval to regulatory bodies.
- Liaise with the company's legal representatives outside of the UK (e.g., EU Authorised Representative) as required.
- Provide guidance, input, and direction for regulatory and quality aspects of new product development programmes to support the company's growth plans.
As the ideal candidate, you will be educated to at least degree level, or equivalent, in a science or engineering discipline. You will have minimum of 5 years' experience in the medical device industry, in a regulatory affairs and/or quality assurance related functions and good knowledge of UK and European regulations and preparing registration submissions having achieved CE Marking for devices that require Notified Body intervention. Experience with the implementation and maintenance of an ISO13485 compliant QMS including interacting with regulatory bodies during audits. You will be enthusiastic, have attention to detail and a desire to work in a fast-paced organisation.
Carbon60, Lorien, SRG - the Impellam Group STEM Portfolio is acting as an Employment Business in relation to this vacancy.
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