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Regulatory Specialist
3 months ago
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.
We're breaking new ground which makes working here exciting, it provides autonomy, opportunity and makes the things you do visible.
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
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:
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