Regulatory Specialist - Cambridge, United Kingdom - CMR Surgical

CMR Surgical

Verified Company

Cambridge, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

We're looking for an exceptional 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.

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:

Support 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
Discuss the registration plan ensuring regular updates are provided to the Registration Manager before initiating the process
Supporting regulatory and related submissions for new and modified devices including CE Technical Documentation
Supporting maintenance of the CE Technical File and GSPR requirements
Support regulatory Intelligence monitoring and communication on new and revised guidelines/regulations
Support assessment of Design Changes impact on the regulatory submissions with oversight from the Regulatory Manager
Updating and maintaining documents in the appropriate document system
Supporting audit preparation relating to the regulatory function
Assisting the CMR organisation in relation to regulatory questions including supporting Tenders

We're a rapidly developing company and roles can change and evolve.

You'll be willing to turn your hand to anything within the XX remit that supports the team with delivering its objectives.

About you:

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

A scientific degree or equivalent medical device regulatory experience (minimum 1 year), experience in surgical robotics would be an advantage
Experienced in the medical device industry, including experience of working with various functions, including R&D and clinical teams
Experience working on Technical Files for CE marking,
Experienced in supporting regulatory strategies for new and modified devices
Excellent oral and written communication skills
Knowledge of relevant medical device regulations, including EU 2017/745 and associated standards, e.g.; ISO 14971, ISO 13485, ISO 6060, ISO 14155, ISO 6230
Experience of Class I and II medical devices.
A knowledge of other global regulations. would be an advantage
Experience in supporting new product development.
Strong attention to detail and the ability to multitask and balance competing priorities
Be proactive and able to work autonomously as required under Manager supervision
The ability to get up to speed quickly and effectively build relationships between Regulatory Affairs and other areas of the organisation
A demonstrable handson approach to regulatory affairs, not being afraid to get involved with real issues and suggest and drive/implement improvements/ efficiencies to existing processes

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:
#LI-Hybrid