Post Market Surveillance Specialist in Cambridge

At CMR Surgical, we are revolutionising the future of minimal access surgery with Versius, our next-generation surgical robotic system. We are growing fast and 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.

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, ensuring 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 events, product malfunctions, 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 submits MDRs/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 will need to have/be:

• Excellent verbal and written communication skills in English.
• Excellent attention to detail.
• Excellent interpersonal, problem-solving, and organisational 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 would love to hear from you! This role requires candidates to have eligibility to work within the UK.