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.
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
ISO 62366
IEC 62304
IEC 82304-1
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 selfmanage 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.
