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 operates in a demanding and continuously evolving environment. The team ensures that CMR Surgical Ltd’s medical devices and related processes comply with all applicable regulatory requirements.
- Support the Regulatory Affairs Manager in developing and executing regulatory strategies to obtain and maintain market clearance or approval for medical devices in key global markets, with a primary focus on European Union EU MDR and United States FDA requirements.
- Prepare high-quality regulatory submissions, support compliance with applicable regulations, and work cross-functionally to integrate regulatory requirements throughout the product development lifecycle.
This role is based on-site at our Cambridge premises.
Responsibilities
- Assist with the preparation, compilation and review of US regulatory submissions, including 510(k)s, Q-Submissions and IDEs, in compliance with 21 CFR requirements, FDA guidance documents and recognised standards.
- Assess the regulatory impact of design, material, labelling and process changes on EU MDR, FDA and other global submissions.
- Provide regulatory input to change control activities to support continued compliance with global requirements.
- Collaborate with cross-functional teams to ensure changes are appropriately documented in Technical Documentation and Design History Files and that relevant global regulatory activities are completed.
- Work closely with R&D, Quality, Clinical and Manufacturing teams to gather required data and documentation, embedding regulatory requirements early to help avoid approval delays.
- Ensure submissions meet regulatory, scientific and quality expectations.
- Support the coordination of responses to questions and deficiency letters from Notified Bodies and the FDA.
Qualifications and Experience:
- Degree or higher qualification in a relevant life science, scientific or engineering discipline; an equivalent combination of education and experience may also be considered.
About you
To be successful in this role, you’ll need to have/be:
- Excellent written and verbal communication skills in English.
- Strong attention to detail and a commitment to producing accurate work.
- Good interpersonal and organisational skills, with the ability to work effectively as part of a team.
- Proficiency with technology, including Microsoft Office.
- Previous experience or exposure to a medical device regulatory or quality environment is desirable.
- A positive, proactive attitude, with a willingness to learn and take on new challenges.
- Ability to manage time effectively and prioritise tasks to meet deadlines.
At CMR we’re building a diverse, inclusive, and authentic workplace; what matters most to us is that you identify with our values and are passionate about making a difference.
Why Join Us?
We offer a competitive salary and a great benefits package including a bonus, pension, healthcare 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
Regulatory Affairs Specialist in Cambridge employer: Cmr Surgical
CMR Surgical is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of Cambridge. Employees benefit from flexible hybrid working arrangements, competitive compensation, and opportunities for professional growth within a pioneering company dedicated to advancing minimal access surgery. Join us to be part of a mission-driven team where your contributions directly impact healthcare outcomes.
