QARA Specialist
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Are you a hands-on Quality Assurance and/or Regulatory Affairs professional looking for your next challenge?
We are looking for proactive individuals who will work closely with cross-functional colleagues to support regulatory activities, maintain quality systems, and contribute to audits, technical documentation, and continuous improvement initiatives.
This role is ideal for individuals who enjoy detail-oriented work, collaboration and who wish to develop their expertise within a regulated MedTech environment on Software as Medical Device (SaMD) products.
Key Responsibilities
- Partake in and manage regulatory compliance activities, including the preparation and submission of regulatory filings, reports, and registrations. Ensure adherence to regulatory requirements throughout Perspectum.
- Independently author SaMD technical file documentation.
- Collaborate with internal teams to ensure regulatory requirements are incorporated into product development, labelling, advertising, and promotional activities.
- Support Notified Body audits to maintain ISO13485 and EU MDR certifications
- Plan and carry out internal audits to verify compliance of internal processes
- Maintain and update SOPs, ensuring alignment with company practices and regulatory requirements
- Support the management of non-conformances, CAPAs, and process improvements
- Participate in SaMD project meetings, providing QARA input throughout development activities
- Design and deliver interactive SOP training workshops
- Evaluate and monitor suppliers, maintaining their approval and validity
- Participate in professional society meetings and share key regulatory updates internally
- Carry out additional QARA-related activities as required
Standards & Regulations You’ll Work With
- ISO 13485
- ISO 14971
- ISO 15223-1
About You
You will be an excellent communicator with strong attention to detail and adopts a methodical approach. You’ll be collaborative, a team player and will help preserve team integrity. Your skills and experience will include:
- Bachelor’s degree in science, technology, engineering, or a related discipline
- Experience working in Quality Assurance and/or Regulatory Affairs within medical devices (SaMD experience desirable)
- Able to self manage administrative tasks and work effectively to deadlines
- Comfortable working independently while knowing when to escalate or seek guidance
- Flexible and adaptable, with a positive approach to hybrid working
- IT literate with ability to pick up new systems with ease
Why Join Us?
This is a great opportunity to work on innovative SaMD technologies with real-world clinical impact. You will join a collaborative, supportive team with plenty of opportunities to build and deepen your QARA expertise in a regulated medtech environment with exposure to global regulatory frameworks and Notified Body interactions.
This role offers hybrid working with flexibility and a preference for time spent in the Oxford office.