Regulatory Affairs Specialist 2 - LATAM Operations & Submissions

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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 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.

Job Overview

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.

Key Responsibilities

• 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 day‑to‑day activities.

Qualifications

Education

• Required: Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or a related discipline.

• Preferred: Regulatory or quality‑related coursework or certification.

Experience and Skills

Required:

• 2 to 4 years of relevant experience in Regulatory Affairs, Regulatory Operations, or a regulated industry environment.
• Experience in medical devices, pharmaceutical, healthcare or another highly regulated industry.
• Working knowledge of regulatory agency requirements, submission processes, documentation requirements, and change control expectations.
• Experience working with controlled documentation systems, regulatory databases, trackers, and records that support inspection readiness and data integrity.
• Strong analytical and investigative skills to assess regulatory requirements, identify risks and support regulatory strategies.
• Strong planning and organizational skills, with the ability to manage multiple priorities and deliverables.
• Clear and effective written and verbal communication.
• Ability to work in a cross-functional, matrixed and multicultural environment.

Preferred:

• Experience supporting Latin America or international cluster regulatory activities.
• Familiarity with ANVISA and other international health authority requirements.
• Exposure to continuous improvement, process optimization, audit support or operational planning.
• Experience using Microsoft Excel, Power BI, or similar tools for data analysis, reporting, and visualization of regulatory activities.

Other

• Languages: Fluency in Spanish ; English (Professional working proficiency).

• Travel: Limited travel may be required (up to ~10%), primarily within the region.

Certifications: Regulatory Affairs Certification (RAC) preferred but not required

 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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Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Collaboration, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments