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
• 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.