Ra Specialist Ii, Latam Ops / Subm

Ra Specialist Ii, Latam Ops / Subm - Detalhes da Vaga. ● 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 FunctionRegulatory Affairs GroupJob Sub FunctionRegulatory AffairsJob CategoryProfessionalAll Job Posting LocationsSão Paulo, BrazilJob DescriptionDePuy 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 OverviewThe 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 daytoday activities. ●QualificationsEducation- Required: Bachelors degree in Life Sciences, Engineering, Pharmacy, or a related discipline. ●- Preferred: Regulatory or qualityrelated coursework or certification. ●Experience and SkillsRequired:- 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 requiredJohnson & 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 under 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 ●Jnj. ●Com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource. ●#LI-Hybrid#DePuySynthesCareersRequired SkillsPreferred SkillsAnalytical 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#J-18808-Ljbffr. 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