Join as Senior Regulatory Affairs Specialist as AMEA apply now 2023
About the job
We are looking for an experienced Senior Regulatory Affairs Specialist with experience in the regulatory device industry to join our growing team to assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products. This is a field-based position but we’ll need you to be based within easy reach of Mumbai. You’ll be working closely with our talented Regulatory team based in Cambridge, UK.
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.
- Reporting to the Regulatory Manager in the UK to ensure all the pre-market regulatory activities are performed and up-to-date, specific to the AMEA region.
- Advising and collaborating with the commercial and regional teams to provide support and guidance on regulatory matters
- Working with distributors
- Managing all aspects of documentation required for application/submission for market authorisation
- Manage license/registration maintenance and renewals
- Manage day to day interactions directly with regional regulatory authorities
- Monitor, assess and deliver requirements for new and evolving regulations
This role will require occasional travel within AMEA.We’re a high growth company and roles can change and evolve. You’ll be willing to turn your hand to anything within the regulatory remit that supports the team with delivering its objectives.
Naturally you’ll have a thorough and sound working knowledge of regulatory compliance in Asia, Middle East and Africa and a track record of successfully gaining regulatory approvals in these markets.We’d also look for you to have:
- Previous experience in the medical device industry is essential for this role
- Experience in all aspects of documentation required for application/submission for market authorisation
- Ability to demonstrate leading and securing market authorisations in markets across AMEA region
- Experience and knowledge of license/registration maintenance and renewals
- Experience of working directly with regional regulatory authorities
- Experience of monitoring, assessing and delivering requirements for new and evolving regulations
- Demonstrated ability to engage/partner with commercial teams
- The ability to build strong working relationships with colleagues throughout the organisation and to communicate effectively at all levels
- A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues
- A perceptive and methodical approach with an ability to communicate effectively and present your plans in a clear and pragmatic way
- A desire to improve and develop existing processes by introducing efficiencies as our business grows
In terms of education, you will have a degree or equivalent in a relevant life science, scientific or engineering-based discipline, a combination of education and experience may be considered. Being computer literate is essential, as is excellent written and verbal English.Why Join Us?We offer a competitive salary and a great benefits package including a bonus, pension and healthcare.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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