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QARA Manager (Part-Time)
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Location: Hybrid/Remote
Commitment: 3 days per week
Type: Contract / Part-Time

 

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About AristonAQ

AristonAQ Ltd is a dynamic and innovative medical device company committed to developing and manufacturing high-quality products that improve patient lives. Based in London, we pride ourselves on our dedication to excellence, regulatory compliance, and fostering a collaborative and supportive work environment. As we continue to grow, we are seeking a talented and motivated Quality Assurance & Regulatory Affairs (QARA) Manager to join our expanding team.

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The Role


As the QARA Manager, you will be responsible for establishing and maintaining our Quality Management System (QMS) and ensuring compliance with relevant regulatory standards. You will work closely with the leadership team to support product development and market entry.


Key Responsibilites

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  • Develop, implement, and maintain the QMS in line with ISO 13485 and ISO 14971 (Risk Management).

  • Ensure compliance with UK MDR 2002 for UKCA marking, EU MDR (2017/745) for CE marking and 21 CFR for FDA clearance.

  • Support regulatory submissions and technical documentation.

  • Prepare and maintain Design History Files (DHF) and Device Master Records (DMR).

  • Conduct internal audits and coordinate external audits.

  • Train and support the team on quality and regulatory processes.

  • Monitor changes in regulations and advise on impact to the business.

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Requirements

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  • Proven experience in Quality Assurance and Regulatory Affairs within medical devices, biotech, or related industries.

  • Strong knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR 2002, and FDA regulations.

  • Familiarity with IEC 62304 (software lifecycle) and IEC 60601 (electrical safety) is a plus.

  • Excellent organizational and communication skills.

  • Ability to work independently in a fast-paced startup environment.

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What We Offer

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  • Flexible part-time schedule (3 days per week).

  • Opportunity to shape the QARA function in a growing startup.

  • Collaborative and innovative work environment.

  • Competitive compensation.

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Interested?

Send your CV and a short cover letter (can be included in the email) to info@aristonaq.co.uk with the subject line: QARA Manager Application – AristonAQ.

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