Specialist, Submission Ops

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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(n) Specialist, Submission Ops, located in SãoPaulo, SãoPaulo, Brazil.

The Specialist, Submission Ops supports regulatory submission operations within QARA International, ensuring accurate, timely, and compliant preparation and lifecycle management of regulatory submissions.

This role plays a critical part in enabling market access, supporting compliance with global and local regulatory requirements, and maintaining high‑quality submission records.

The position offers exposure to global regulatory operations and the opportunity to contribute directly to patient safety and business continuity at DePuy Synthes.

Key Responsibilities


* Support the preparation, assembly, publishing, and tracking of regulatory submissions and related documentation in accordance with internal procedures and regulatory requirements.



* Maintain accurate regulatory records, submission trackers, and document repositories to support submission lifecycle management.



* Coordinate submission activities with Regulatory Affairs, Quality, and cross‑functional partners to ensure completeness and on‑time delivery.



* Perform quality checks on submission content and formatting to ensure accuracy, consistency, and compliance with defined standards.



* Support responses to health authority requests by compiling documentation and tracking commitments under guidance from regulatory leads.



* Assist with process improvements, metrics, and reporting to enhance submission operational efficiency.



* Support local systems access management.



* Support contract management and payment processes.



* Apply DePuy Synthes and Johnson & Johnson quality, compliance, and Credo principles in all submission‑related activities.

Qualifications

Education


* Bachelor's degree required in Life Sciences, Regulatory Affairs, Quality, Engineering, or a related discipline.



* Regulatory or quality‑related coursework or certification p...