Specialist Submission Operations

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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, located in São Paulo, São Paulo, 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 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, career and 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. #LI-Hybrid #DePuySynthesCareers Required Skills: Preferred Skills: