Specialist, Submission Ops

Johnson & Johnson Innovative Medicine; São Paulo; Presencial; BRL 50 000 - 80 000; Tempo integral

Resumo da oferta

Johnson & Johnson’s DePuy Synthes unit in São Paulo, Brazil is recruiting a Specialist, Submission Ops to support regulatory submission operations. The role ensures accurate, timely, and compliant preparation and lifecycle management of submissions across global and local requirements.

Responsibilities include document preparation, record-keeping, cross‑functional coordination, content quality checks, and support for health authority responses.

Qualificações

• Foundational knowledge of regulatory submission processes and documentation practices.
• Strong attention to detail and ability to manage documentation accurately and consistently.

Responsabilidades

• Support the preparation, assembly, publishing, and tracking of regulatory submissions and related documentation.
• 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‑timedelivery.
• 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.

Conhecimentos

Regulatory knowledge

Attention to detail

Time management

Communication

Formação académica

Bachelor's degree in Life Sciences

Regulatory or quality coursework

Ferramentas

Regulatory information management systems

Document management systems

Descrição da oferta de emprego

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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,locatedin SãoPaulo, SãoPaulo, Brazil.

The Specialist, Submission Ops supports regulatory submission operations within QARA International, ensuringaccurate,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, andmaintaininghigh‑qualitysubmission 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 within 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‑timedelivery.

• 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 related discipline.

• Regulatory or quality‑related coursework or certification preferred.

Experience and Skills

Required

• Generally requires 0–2 years of relevant experience in regulatory operations, quality, or a regulated environment, aligned to a developing professional‑level role.

• 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 or inspection readiness activities.

• Experience working in a global or matrixed organization.

• Effective written and verbal communication skills.

Other

• Languages: Portuguese required; English proficiency preferred for global collaboration.

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

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

For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visit www.careers.jnj.com.

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 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.

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 https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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