We are looking for a Senior / Lead Regulatory Affairs Specialist to assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified product. Reporting to the Regulatory Manager to ensure all the pre-market regulatory activities are performed and up-to-date, specific to the LATAM region.
This is a hybrid role and would be based in our Sao Paulo office 2 to 3 days a week.
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.
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
- 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
About you
- Ability to demonstrate supporting market authorisations in markets across LATAM region
- 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
- 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.
- 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
- A degree or higher, or equivalent in a relevant life science, scientific or engineering-based discipline, a combination of education and experience may be considered.
- Computer literacy is essential
- Excellent written & verbal English. Spanish language skills would be beneficial
- You will also need to be able to travel occasionally, if required within the region of responsibility
Why Join Us?
We offer a competitive salary and a great benefits package including a bonus, healthcare, an annual personal day for every employee to use however they wish and enhanced global parental leave pay.
Interested? We’d love to hear from you!
This role requires candidates to have eligibility to work within Brazil
Strictly no agencies
