RA Specialist II, LATAM Ops / Subm

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 Regulatory Affairs Specialist II, LATAM Operations & Submissions. Johnson & Johnson announced plans to separate our Orthopedics business to establish a standalone orthopedics 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.

The Regulatory Affairs Specialist II, LATAM Operations & Submissions will support regulatory strategy, regulatory operations and submission planning activities across LATAM within QARA International. This role will provide regulatory guidance, support documentation readiness and partner with local affiliates to enable compliant product registrations and lifecycle management activities across international markets. This position offers direct involvement in global regulatory processes, cross-functional collaboration, and meaningful impact on patient access to DePuy Synthes orthopedic solutions.

Support regulatory strategy, regulatory operations and submission planning activities across LATAM, ensuring alignment with local regulatory requirements and internal procedures. Apply functional analysis and interpretation of regulatory strategies to assess risks and support implementation planning across LATAM. Interpret and support the implementation of new and changing government regulations to ensure compliance with regulatory requirements and government standards. Provide regulatory guidance and supporting documentation to local affiliates for new product registrations, lifecycle updates, renewals, changes and market maintenance activities. Support regulatory submission activities with internal partners, including Quality, Supply Chain, R&D, Commercial and local Regulatory Affairs teams. Communicate regulatory strategies, priorities, documentation needs and follow-ups clearly with stakeholders. Execute established regulatory operations processes, ensuring compliance with internal procedures and external regulations. Maintain accurate regulatory records, trackers and databases to support inspection readiness, traceability and data integrity. Identify opportunities to improve efficiency, quality and timeliness of regulatory activities while maintaining compliance and audit readiness. Apply DePuy Synthes and Johnson & Johnson quality, compliance, and Credo principles in all