RA Specialist II, LATAM Ops / Subm

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Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
São Paulo, Brazil

Job Description:

DePuy Synthes is recruiting for a Regulatory Affairs Specialist II, LATAM Operations & Submissions.

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 Regulatory Affairs Specialist II, LATAM Operations & Submissions will support regulatory strategy, regulatory operations and submission planning activities across LATAM within QARA International.

This role will provide regulatory guidance, support documentation readiness and partner with local affiliates to enable compliant product registrations and lifecycle management activities across international markets.

This position offers direct involvement in global regulatory processes, cross-functional collaboration, and meaningful impact on patient access to DePuy Synthes orthopedic solutions.

Key Responsibilities


* Support regulatory strategy, regulatory operations and submission planning activities across LATAM, ensuring alignment with local regulatory requirements and internal procedures.


* Apply functional analysis and interpretation of regulatory strategies to assess risks and support implementation planning across LATAM.


* Interpret and support the implementation of new and c...