Specialist Submission Operations

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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 Opslocatedin SãoPaulo SãoPaulo Brazil.

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.

For more information on how we support the whole health of our employees throughout their wellnesscareerand life journey please visit.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics 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 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

Required Experience:

IC

Employment Type : Full-Time
Experience: years
Vacancy: 1