Specialist Submission Operations

The Specialist Submission Ops supports regulatory submission operations within QARA International ensuringaccuratetimely 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 andmaintaininghighqualitysubmission 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 documentationin accordance withinternal procedures and regulatory requirements.

• Maintainaccurateregulatory records submission trackers and document repositories to supportsubmissionlifecycle management.

• Coordinate submission activities with Regulatory Affairs Quality andcrossfunctionalpartners to ensure completeness andontimedelivery.

• 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.

• Assistwith process improvements metrics and reporting to enhance submission operational efficiency.

• Support local systemsaccess management.

• Support contract management and payment processes.

• Apply DePuy Synthes and Johnson & Johnson quality compliance and Credo principles in allsubmissionrelatedactivities.

Qualifications

Education

• Bachelors degreein Life Sciences Regulatory Affairs Quality Engineering ora relateddiscipline.

• Regulatory orqualityrelatedcoursework or certification preferred.

Experience and Skills

• Generallyrequires02 years of relevant experiencein regulatory operations quality or a regulated environment aligned to a developingprofessionallevelrole.

• Foundational knowledge of regulatory submission processes and documentation practices.

• Strong attention to detail and ability to manage documentation accurately and consistently.

• Ability to follow defined procedures and manage multiple tasks with competing priorities.

• Basic data analysis and reporting skills to support submission tracking and metrics.

Preferred

• Experience in a regulated industry such as medical devices pharmaceuticals or healthcare.

• Familiarity with global regulatory requirements and submission standards.

• Experience using regulatory information management or document management systems.

• Exposure to audit orinspectionreadiness activities.

• Experience working in a global or matrixed organization.

• Effective written and verbal communication skills.

Other

• Languages:Portuguese; Englishproficiencypreferred for global collaboration.

• Travel:Limited domestic or international travel may be(generally <10%).

• Certifications:Regulatory Affairs Certification (RAC) or similar preferred but not.

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