This range is provided by Premier Group. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Overview
JOB – QARA Manager (Medical Devices)
TERM – Permanent
SALARY – £50,000 to £70,000 per annum (plus benefits)
My client is a leading medical device manufacturer providing innovative products to the healthcare sector. They are looking to take on a QARA Manager to lead both Quality Assurance and Regulatory Affairs activities at their site in Stevenage.
The QARA Manager will ideally have the following attributes:
* Proven experience in a QARA or Quality/Regulatory Management role within the medical device industry
* Strong knowledge of ISO 13485, EU MDR, FDA 21 CFR Part 820, and other regulatory frameworks
* Experience with design assurance, validation, risk management, and technical file submissions
* Proven track record of managing external audits, inspections, and notified body interactions
* Ability to develop and implement regulatory strategies for product approvals and compliance
* Strong leadership skills with the ability to mentor and manage a quality and regulatory team
* Excellent communication skills (both written and verbal)
The QARA Manager role will involve:
* Leading all aspects of Quality Assurance and Regulatory Affairs across the business
* Maintaining and improving the company’s QMS to ensure compliance with ISO 13485 and global regulations
* Overseeing product regulatory submissions and approvals (EU MDR, FDA, international markets)
* Managing audits, inspections, and certification activities
* Providing guidance on design control, risk management, and validation throughout the product lifecycle
* Liaising with internal teams including R&D, production, and supply chain to ensure compliance
* Driving continuous improvement across quality and regulatory processes
* Reporting compliance and regulatory status to senior management
If you are interested in this position, please apply with an up-to-date CV as soon as possible, along with your availability and salary expectations.
Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance, Manufacturing, and Production
* Industries: Industrial Machinery Manufacturing, Machinery Manufacturing, Medical Equipment Manufacturing
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