Regulatory Affairs Specialist (São Paulo)

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.

• 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

#LI-LATAM