Specialist, Submission Ops (Regulatory Affairs)

Location: São Paulo, Brazil; hybrid work. Limited domestic or international travel may be required, generally less than 10%.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions, with DePuy Synthes focused on orthopaedics.

What you will do

• Prepare, assemble, publish, and track regulatory submissions and related documentation.
• Maintain submission trackers, regulatory records, and document repositories throughout the submission lifecycle.
• Coordinate submission activities with Regulatory Affairs, Quality, and cross-functional partners.
• Perform quality checks for submission accuracy, consistency, formatting, and compliance.
• Compile documentation for health authority responses and track commitments under regulatory guidance.
• Support process improvements, metrics, reporting, systems access, contract management, and payment processes.

Requirements

• Bachelor’s degree in Life Sciences, Regulatory Affairs, Quality, Engineering, or a related discipline.
• 0–2 years of relevant experience in regulatory operations, quality, or another regulated environment.
• Foundational knowledge of regulatory submission processes and documentation practices.
• Strong attention to detail, accurate documentation management, and the ability to follow defined procedures while managing competing priorities.
• Basic data analysis and reporting skills for submission tracking and metrics.
• Portuguese is required. English proficiency is preferred for global collaboration.

Nice to have

• Experience in medical devices, pharmaceuticals, healthcare, or another regulated industry.
• Familiarity with global regulatory requirements, submission standards, and regulatory or document management systems.
• Exposure to audit or inspection readiness activities and global or matrixed organizations.
• Regulatory Affairs Certification (RAC) or a similar certification.

Culture & Benefits

• Inclusive work environment guided by Johnson & Johnson’s Credo principles.
• Opportunity to contribute to patient safety, market access, compliance, and business continuity.
• Exposure to global regulatory operations and cross-functional collaboration.
• Employment is expected to transition to DePuy Synthes following the planned separation of the Orthopaedics business, subject to legal and regulatory approvals.