Manager, Regulatory Affairs Brazil - DEPUY SYNTHES

At 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 the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function: Regulatory Affairs Job Category: People Leader All Job Posting Locations: São Paulo, Brazil Job Description: Manager, Regulatory Affairs Brazil Job ID: 10021983 Location: São Paulo, São Paulo, Brazil DePuy Synthes is recruiting for a(n) Manager, Regulatory Affairs Brazil, located in São Paulo, São Paulo, Brazil. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

The Manager, Regulatory Affairs Brazil provides regulatory leadership to support the successful introduction, maintenance, and compliance of DePuy Synthes medical devices in the Brazil market. This role plays a critical part in enabling patient access to innovative orthopedic solutions while ensuring adherence to local regulatory requirements. The position offers the opportunity to work cross‑functionally and influence business outcomes in a dynamic, highly regulated environment.

Lead and manage regulatory submission, approval, and lifecycle activities for medical devices in Brazil. Develop and execute regulatory strategies that support new product introductions, product changes, and ongoing compliance. Prepare, submit, and maintain regulatory dossiers, registrations, renewals, and notifications in accordance with local requirements. Act as the primary regulatory liaison with Brazilian health authorities, maintaining effective and professional working relationships. Interpret regulatory requirements and clearly communicate risks, timelines, and impacts to internal stakeholders. Partner with Quality, Supply Chain, R&D, and Commercial teams to ensure regulatory compliance throughout the product lifecycle. Support regulatory inspections, audits, and inquiries, ensuring accurate responses and timely resolution of commitments. Contribute to continuous improvement of regulatory processes and promote a strong culture of compliance. Provide guidance, coaching, and day‑to‑day direction to regulatory team members or project contributors, as applicable.

Education Bachelor’s degree required in life sciences, engineering, or a related scientific discipline. Advanced degree preferred. Experience and Skills Required: 6–8 years of progressive experience in Regulatory Affairs within the medical device industry. Strong knowledge of regulatory