About CMR Surgical

At CMR Surgical, we're revolutionising the future of minimal access surgery with Versius, our next-generation surgical robotic system. We're growing fast, and we’re on a mission to transform how surgery is delivered globally—for the benefit of patients, clinicians, and healthcare systems.

Our values—Ambitious, Humble, People-Focused, and Fair & Responsible—define our approach to innovation, partnership, and growth. If you believe in making a meaningful difference in healthcare and want to be part of a purpose-driven company with bold ambitions, now is the time to join us.

CMR is an exciting and evolving company to be joining right now.  Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals.

We’re breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible. Come and join us and see what you’re capable of.

About the Role

Regulatory Affairs is a demanding and continuously evolving regulatory environment that works to ensure that the medical devices and processes of CMR Surgical Ltd are compliant with all relevant regulations.

Vigilance/Medical device reporting (MDR) is a critical process, within Post-Market Surveillance, that ensures the safety and effectiveness of medical devices by monitoring incidents/adverse events and reporting them to regulatory authorities.

Your role within the Regulatory Affairs Post-Market team will be to support vigilance/MDR reporting to the USA, UK, EU and other regions. You will work in collaboration with regional experts and internal subject matter experts to evaluate the reportability of complaints in all relevant geographies. You will communicate reportable events to national competent authorities and be responsible for following up and responding to any queries that may arise.

This role will be hybrid, with a minimum of 3 days a week at our Cambridge office.

Responsibilities

• Reviews, evaluates, classifies potential reportable complaints as serious incidents, adverse event, product malfunction or non-reportable for U.S., EU, UK and International affiliates.
• Responsible for timely regulatory reporting and accurate/precise documentation.
• Processes medical device reports and non-reportable justifications within the complaint handling system and submit MDR's/MIR/Vigilance Reports with global Health Authorities as required.
• Communicates with product quality/technical service representatives, when clarification is required.
• Confers with co-workers and clinical representatives to reach a decision regarding a potential reportable complaint’s classification.
• Have input to the complaint and vigilance standard operating procedures.
• Assist and participate in complaint and vigilance meetings as appropriate
• Maintain awareness of complaint and vigilance legislation and guidelines.
• Participate in a team of people capable of meeting the company’s quality objectives
• Any other duties, within reason and capability, as determined by company management.

About You

To be successful in this role, you’ll need to have/be:

• Excellent verbal and written communication skills in English.
• Excellent attention to detail.
• Excellent interpersonal, problem-solving, and organizational skills.
• Proficient in the use of technology including MS Office. Familiarity with Atlassian Jira is beneficial.
• Experience of dealing with report submission to regulatory authorities, ideally with experience of medical device vigilance would be beneficial
• Background in regulatory or quality would be beneficial
• Hands-on approach, with a “can do” attitude
• Ability to prioritise, demonstrating good time management skills

Why Join Us?

We offer a competitive salary and a great benefits package including a bonus, non-contributory pension, private healthcare, generous annual leave allowance and enhanced global parental leave pay.

Interested? We’d love to hear from you!

This role requires candidates to have eligibility to work within the UK.

Strictly no agencies