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Job Title:

Quality Assurance Regulatory Affairs Manager - 10661

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Job Type: Permanent

Our Client is seeking an experienced Quality Assurance Regulatory Affairs Manager.  The role is offered as a full-time permanent position, no hybrid working available.


Salary:             Competitive - disclosed on application

Location:         Kent

Benefits:          25 days leave + 8 BH, pension, health care, free parking and more



This is an exciting opportunity to become part of our client’s management team - the role has one direct report with expansion plans in the future.


The role of Quality Assurance Regulatory Affairs Manager requires an experienced and professional candidate to lead the quality assurance and regulatory affairs activities.  As a manufacturer this is an important and responsible role and for the right candidate, would provide a very rewarding challenge.


The Quality Assurance Regulatory Affairs Manager position has overall responsibility for the quality management system and for compliance to the required regulatory standards within the industry. This role will have responsibility for overseeing technical files to ensure they comply with industry regulations.  Experience and an understanding of the requirements of ISO 13485, MDR/MDD, FDA 21 CFR 820 and cGMP would be strongly desirable and advantageous.


A key area of the Quality Assurance Regulatory Affairs Manager role would be to take the lead in quality and regulatory audits and work closely with external audit bodies and competent authorities to demonstrate the company’s compliance.  The role would also head up the QMS management review on an annual basis.


As Quality Assurance Regulatory Affairs Manager you would take the lead in ensuring a successful transition from EU MDD to EU MDR requirements and would need to manage associated deadlines with this project, whilst ensuring full compliance with UK MDR requirements (and UKCA once the regulation is published).


The Quality Assurance Regulatory Affairs Manager will take charge of the CAPA process and be responsible for the investigation of customer complaints, non-conformities and quality defects.  The role will also provide the final batch release sign off required for all products leaving the manufacturing site.

To apply, please email apply@reactrecruitment.co.uk

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