Careers

CMR Surgical; Brasil; Presencial; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

Join a forward-thinking company as a Senior Regulatory Affairs Specialist, where your expertise in regulatory compliance will help shape the future of medical devices in the LATAM region. You'll be at the forefront of ensuring that all regulatory activities are up-to-date while collaborating with diverse teams. This role offers a unique opportunity to make a significant impact in an innovative environment that values autonomy and personal growth. If you're passionate about regulatory affairs and want to contribute to groundbreaking advancements in surgical technology, this is the perfect opportunity for you.

Serviços

Competitive Salary

Bonus

Non-contributory Pension

Private Healthcare

Annual Personal Day

Enhanced Parental Leave

Qualificações

• Thorough knowledge of regulatory compliance in LATAM markets.
• Experience in medical device industry and market authorizations.

Responsabilidades

• Manage pre-market regulatory activities for LATAM region.
• Collaborate with teams on regulatory matters and documentation.
• Engage with regional regulatory authorities and monitor regulations.

Conhecimentos

Regulatory Compliance

Documentation for Market Authorization

Collaboration with Commercial Teams

Communication Skills

Problem-Solving

Formação académica

Degree in Life Science or Engineering

Descrição da oferta de emprego

Senior Regulatory Affairs Specialist - LATAM

We are looking for an experienced Regulatory Affairs Specialist 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.

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

Reporting to the Regulatory Manager to ensure all the pre-market regulatory activities are performed and up-to-date, specific to the LATAM region.

1. Advising and collaborating with the commercial and regional teams to provide support and guidance on regulatory matters.
2. Working with distributors.
3. Managing all aspects of documentation required for application/submission for market authorisation.
4. Managing license/registration maintenance and renewals.
5. Managing day-to-day interactions directly with regional regulatory authorities.
6. Monitoring, assessing, and delivering requirements for new and evolving regulations.

We’re a rapidly developing company and roles can change and evolve. You’ll be willing to turn your hand to anything within the Regulatory Affairs remit that supports the team with delivering its objectives.

About You

Naturally, you’ll have a thorough and sound working knowledge of regulatory compliance in Latin American markets and a track record of successfully supporting regulatory filings in these markets.

We’d also look for you to have:

1. Previous experience in the medical device industry is essential for this role.
2. Experience in all aspects of documentation required for application/submission for market authorisation.
3. Ability to demonstrate supporting market authorisations in markets across the LATAM region.
4. Experience and knowledge of license/registration maintenance and renewals.
5. Experience of working directly with regional regulatory authorities.
6. Experience of monitoring, assessing, and delivering requirements for new and evolving regulations.
7. Demonstrated ability to engage/partner with commercial teams.
8. The ability to build strong working relationships with colleagues throughout the organisation and to communicate effectively at all levels.
9. A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues.
10. A perceptive and methodical approach with an ability to communicate effectively and present your plans in a clear and pragmatic way.
11. 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 higher in a relevant life science, scientific or engineering-based discipline, or equivalent. Being computer literate is essential, as is excellent written and verbal English. You may 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, 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 if you need a taxi for access needs.

Interested? We’d love to hear from you!

This role requires candidates to have eligibility to work within Brazil.