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.
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.
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:
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.
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.