Quality and Regulatory Affairs Manager – In vitro Diagnostics / Medical Devices
Our client is a leading developer of diagnostic tests for the women’s fertility sector. With further growth planned, they now wish to appoint an experienced quality management professional to head up the quality and regulatory functions within the business.
Key responsibilities include assisting in: batch release, document review; quality audits; preparing process validation protocols, recommending process improvements and ensuring compliance with the Quality Management System, which is accredited to ISO 13485. In addition, the role will manage the Quality Officer and fulfil the role of management representative as defined within ISO13485.
- To adhere to all aspects of the company quality policy
- Administer and develop, as required, the quality management system and supporting procedures
- Capable of meeting ISO 13485, including CAPA, Complaint Management, Document Control, Change Control, Internal Auditing, Risk Management, Supplier Controls and Validation protocols.
- Develop and maintain submissions to regulatory agencies required to allow company to be sold in all regions and markets.
- Manage auditing activities from the different Notified Bodies and Competent Authorities.
- Manage staff activities to ensure adherence to producing a quality product and to conform to the company Quality Management System.
- Monitor regulatory agencies for changes in policies and procedures and implement changes as required to maintain registrations.
- Develop quality system documentation to maintain compliance to address new and updated standards and guidance’s, as required.
Qualifications and Experience
- Educated to degree level in a scientific or engineering discipline
- Experience of working in the medical device / diagnostics sector
- 5 years experience working within ISO 13485
- 3 years of experience working with Quality Management Systems
- 3 years experience within regulatory affairs
- Experience with the product development cycle and process validation
- Computer literate – experienced using Microsoft Office Problem solving Literate and numerate Full UK Driving licence.
Based South East
Negotiable salary + Benefits
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