Manager, Regulatory Affairs Brazil - DEPUY SYNTHES

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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.
Job Overview

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.
Key Responsibilities


* 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 reg...