Quality & Regulatory Associate
Are you passionate about quality, regulatory affairs, and making a real impact in the medical device industry? I'm looking for a dedicated Quality & Regulatory Associate to join a friendly, down to earth team and play a key role in ensuring the highest standards across the product portfolio and operations.
About the Role
In this pivotal position, you will drive quality and regulatory activities across multiple sites, ensuring compliance with industry standards and supporting continuous improvement. You'll maintain technical documentation for manufactured product ranges, lead investigations into product non-conformities, and help shape processes that meet stringent regulatory requirements.
What You’ll Be Doing
* Developing and improving processes to meet relevant standards and regulations
* Creating and maintaining technical documentation for a wide range of medical devices
* Managing external product listings
* Working with R&D and design teams on product updates and new launches
* Planning and conducting internal and supplier audits
* Supporting regulatory and quality audits with documentation and on-site assistance
* Managing and investigating non-conformities, including CAPAs and NC reports
* Conducting supplier evaluations and supporting compliance meetings
What We’re Looking For
Essential:
* Experience in a Quality and/or Regulatory role within the Medical Device sector
* Strong understanding of recognised QMS frameworks (ISO 13485 or ISO 9001 minimum)
* Internal auditing experience
* Hands-on experience with CAPA and root cause analysis
* Ability to write processes aligned with regulatory standards
* Knowledge of MDR requirements
* Understanding of MHRA reporting
Why Join?
This is an exciting opportunity to work across diverse product ranges and play a central role in shaping quality and regulatory excellence. You’ll collaborate with teams across the business and be empowered to influence real change.
If you’re ready to take the next step in your quality and regulatory career, we’d love to hear from you.