We're looking to recruit an exceptional Regulatory Affairs professional for this key role, which 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.

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

• Manage and drive country regulatory registrations in the EU and other markets as defined in the CMR market strategy
• Correspond with the respective regulatory agencies as required to ensure compliance to country specific requirements
• Work autonomously on the registration plan ensuring regular updates are provided to the Registration Manager
• Drafting and managing the regulatory strategy for new and modified devices, including interactions with project teams/subject matter experts within CMR and respective global markets
• Drafting and managing regulatory and related submissions for new and modified devices including CE Technical Documentation
• Working knowledge of EU requirements related to EU MDR
• Working knowledge of post-market requirements including vigilance and field actions
• Checking and maintaining the Technical File and GSPR requirements including discussions with various internal department as required, including interactions with the Notified Body, as required
• Providing training to departmental personnel on regulatory activities e.g. Tech File, GSPR, etc
• Regulatory Intelligence monitoring and communication on new and revised guidelines/regulations
• Assessing Design Changes impact on the regulatory submissions
• Updating and maintaining documents in the appropriate document system
• Supporting audit preparation and participation relating to the regulatory function
• Assisting the CMR organisation in relation to regulatory questions including supporting Tenders

We’re a rapidly developing company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Regulatory Affairs Team's remit that helps the team deliver its objectives

About you

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

• Competencies in strategic thinking, data, and impact analysis
• Excellent oral and written communication skills
• Ability to present confidently within CMR and with regulatory authorities on specific regulatory issues
• A strong attention to detail and the ability to multi-task and balance competing priorities
• Be proactive and able to work autonomously within minimal supervision
• 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 drive/implement improvements/ efficiencies to existing processes
• A scientific degree or equivalent medical device regulatory experience, experience in surgical robotics would be an advantage
• Experienced in the medical device industry, including working collaboratively with various functions, including R&D and clinical teams
• Experienced in creation and maintenance of Technical Files for CE marking including associated documentation linked to EU MDR
• Experienced in development of regulatory strategies and engagement in the Design Control process from design to market phase (new and modified devices)

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.  

CMR can support with travel reimbursement for in-person interviews, providing you live a certain distance from our offices/ sites or if you need a taxi for access needs. Please just get in touch with us interviews@cmrsurgical.com if you have any questions about this, we’re happy to help.

Interested? We’d love to hear from you!