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QARA Officer

Job Posted: a month ago

Salary: £ 40,000 - 40,000 / Annum
Job Type: Contract
Location: Bristol, City of Bristol

Expire in: 17 hours

Job Description

A growing medical device manufacturer & distributor in Bristol Area is looking to add a Quality & Regulatory Officer to their UK team, supporting manufacturing, distribution, new product development and international markets.
This is a hands-on role covering ISO 13485 quality systems and global regulatory compliance, ideal for someone who enjoys owning processes end-to-end and working closely with operations, suppliers and regulatory bodies.
What you’ll be doing:
  * Maintaining and improving the ISO 13485 / ISO 9001 Quality Management System Ensuring compliance with UKCA, EU MDR, FDA 21 CFR Part 820 and other global regulations
  * Managing Notified Body and Competent Authority audits (surveillance & recertification)
  * Leading complaints, CAPAs, vigilance, FSCA/FSN and non-conformance investigations
  * Owning technical files, risk management files and DHF/DMR documentation
  * Supporting post-market surveillance and clinical evaluation activities
  * Reviewing and approving labelling, IFUs, artwork and promotional materials
  * Supporting supplier quality, audits and risk reviews
  * Providing QARA input into new product development and change control
  * Supporting product registrations across UK, EU and ROW markets
What we’re looking for:
  * Experience in Quality & Regulatory roles within medical devices
  * Strong knowledge of ISO 13485 and medical device regulations
  * Confidence working with technical files, risk management and audits
  * Comfortable operating in a manufacturing and distribution environment
  * Ability to work cross-functionally with operations, suppliers and management
  * Degree in Engineering, Life Sciences or equivalent experience preferred
If you’re a hands-on QARA professional looking for a role with real ownership and exposure across the full product lifecycle, this one’s worth a conversation

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