
Regulatory Affairs Specialist
Há 3 dias
Life Unlimited.
At Smith+Nephew, we design and manufacture technology that takes the limits off living
About The Role
Imagine a role where you're not just part of the process, you redefine it. At the heart of our innovative medical devices' company, we're looking for a trailblazer to join our Regulatory Operations team in Brazil. This isn't your typical regulatory role.
Experience in the medical devices, responsible for registration, certification, and regulatory maintenance of medical devices across different risk classes (I to IV), with focus on regulatory compliance in Brazil and other Latin American countries.
What Will You Be Doing?
- Key responsibilities include managing certification processes with regulatory bodies such as ANVISA, INMETRO and ANATEL; preparing, reviewing, and submitting registration dossiers; obtaining Good Manufacturing Practices (GMP) certifications; and ensuring compliance with local and regional requirements.
- This professional will participate in regional regulatory projects, keep regulatory databases and product registrations up to date, and handle renewals, amendments, and maintenance of registrations. The role requires direct interaction with distributors, regulatory consultants, and health authorities, as well as continuous monitoring of regulatory changes across LATAM countries. The position also provides technical-regulatory support to internal departments such as Quality, Commercial, and Operations, and involves participation in internal and external audits.
What will you need to be successful?
- Requirements include a university degree in Pharmacy, Biomedical Engineering, Biomedicine, or related fields; proven experience in regulatory affairs for medical devices; product registration expertise; knowledge of INMETRO, ANATEL, and GMP certifications; and preferably experience with LATAM regulations.
- Fluent English, communication skills, organizational ability, and collaborative work style.
- Preferred qualifications: postgraduate degree or specialization in Regulatory Affairs, and intermediate to advanced Spanish.
You. Unlimited.
We believe in crafting the greatest good for society. Our strongest investments are in our people and the patients we serve.
- Inclusion and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website.
- Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options.
- Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities
- Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more.
- Flexibility: Hybrid Working Model (For most professional roles).
- Training: Hands-On, Team-Customized, Mentorship
Stay connected by joining our Talent Community.
We're more than just a company - we're a community Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into
You. Unlimited.
, life, culture, and benefits at S+N.
Explore our website and learn more about our mission, our team, and the opportunities we offer.
-
Regulatory Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil EBANX Tempo inteiroBuild your future with Sovos. If you\'re seeking a career where innovation meets impact, you\'ve come to the right place. As a global leader, Sovos is transforming tax compliance from a business requirement to a force for growth while revolutionizing how businesses navigate the e... Regulatory Affairs Specialist We are seeking a Regulatory Affairs...
-
Governmental & Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil UBS Tempo inteiroGovernmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Job Reference # BRJob TypeFull TimeYour roleAre you curious, have attention to detail and the ability to...
-
Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Alimentiv Inc. Tempo inteiroResponsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools,...
-
Senior Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil BOEING Tempo inteiroAt Boeing, we innovate and collaborate to make the world a better place. From the seabed to outer space, you can contribute to work that matters with a company where diversity, equity and inclusion are shared values. We're committed to fostering an environment for every teammate that's welcoming, respectful and inclusive, with great opportunity for...
-
Regulatory Affairs Senior Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiroQuality Assurance Regulatory Affairs ManagerJob Summary:Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents to...
-
Regulatory Affairs Manager
3 semanas atrás
São Paulo, São Paulo, Brasil Essity Tempo inteiro**Regulatory Affairs Manager LATAM**:**Trabalhar na Essity não é apenas uma carreira, é uma chance de tornar o mundo um lugar mais saudável, higiênico e seguro. Com inovações impactantes, juntamente com soluções sustentáveis, nos esforçamos para alcançar mais pessoas a cada ano com as soluções necessárias e essenciais para o bem-estar.****A...
-
Regulatory Specialist
Há 5 dias
São Paulo, São Paulo, Brasil Fortrea Tempo inteiro R$60.000 - R$120.000 por anoRegulatory Affairs Specialist – Global Submissions & Quality DocumentationJoin Fortrea's dynamic global team supporting pharmaceutical product development and lifecycle management. In this role, you'll be responsible for preparing, reviewing, and managing regulatory and quality documentation for submissions to health authorities across the US, EU, and...
-
Manager, Regulatory Affairs
3 semanas atrás
São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiroQuality Assurance Regulatory Affairs ManagerJob Summary: Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents...
-
Regulatory Affairs Senior Analyst
Há 3 dias
São Paulo, São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro R$104.000 - R$156.000 por anoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Regulatory Affairs Senior Analyst
Há 3 dias
São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro R$104.000 - R$156.000 por anoAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...