We’re looking for an exceptional Senior Regulatory Specialist to join our Regulatory Affairs Team, based in Cambridge. Reporting to the respective Regulatory Manager. This role will play an essential part in ensuring the efficient co-ordination of CMR Surgical’ s regulatory requirements for the UK, EU and International markets. This is a fantastic opportunity to be part of a successful organisation and to play an integral role in our mission to provide access to minimum access surgery to everyone who needs it.

This role is offered on a hybrid basis, with a minimum of 3 days a week being based in the office. However, we are open to considering candidates who are looking for greater flexibility.

About CMR Surgical

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.

At CMR we’re pushing boundaries – enhancing immense human skill with technology to deliver the best surgical care which is why we’re proud to be the Official Medical Device Partner of ParalympicsGB, the team of elite athletes that challenge perceptions of what humans can achieve. The team that inspires us with their determination, their precision and control.

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.

Responsibilities

• Reporting to the Regulatory Affairs Manager to ensure all the post-market regulatory activities are performed and compliant
• Advising and steering the clinical team in clinical study requirements, and clinical development plan
• Have oversight of clinical development (pre-and post market activities) as well as overall responsibility for ensuring sufficient clinical data for conformity assessment and application submission for market authorisation
• Preparing and updating CER, PMS/PMCF plan and PSUR as required

About you

Naturally you’ll have a thorough & sound working knowledge of medical device regulatory compliance in any of the following: Europe, USA, China and Japan, and a track record of successfully gaining regulatory approvals in various markets. Clinical regulatory experience within the medical device industry is essential and we’d also look for you to have experience of:

• Experience of CER writing and maintenance, including all associated PMS plans and reports as required by EU MDR for class 1, and class 2a and 2b medical devices Have a working knowledge of EU MDR clinical aspects.
• Revising literature review processes (ongoing and periodic) as required
• A Bachelor’s degree in Science or Engineering or equivalent on the job experience
• A strong attention to detail and the ability to multi-task and balance competing priorities
• The ability to get up to speed quickly and effectively build relationships between Regulatory Affairs and other areas of the organisation
• A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues and suggest and implement improvements/ efficiencies to existing processes
• Effective communications skills, with experience of presenting plans in a clear and pragmatic way to colleagues and stakeholders across all levels
• People management skills would be an advantage

We’re a rapidly developing company and roles can change and evolve. You’ll be willing to turn your hand to anything within the Regulatory Affairs remit that supports the team with delivering its objectives

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 so don’t be put off applying if your experience isn't perfectly matched with this role.

We’d really like to hear from applicants from underrepresented groups and we recognise everyone has individual personal circumstances, so we’re open to discussing reduced / flexible / hybrid working hours for this role.

Why Join Us?

We offer a competitive salary and a great benefits package including a bonus, non-contributory pension, private healthcare which covers pre-existing conditions, annual personal day for every employee to use however they wish and enhanced global parental leave pay.

We recognise that everyone has a life outside of work and at times we can experience things which are significant and can impact on our working lives. We’ve just launched our Global Parental Leave and Health and Wellbeing leave supporting our colleagues going through the menopause, fertility cycles or pregnancy loss and those going through gender reassignment; allowing them time to look after themselves and those close to them.  

Interested? We’d love to hear from you!