Regulatory Affairs Senior Specialist

Overview Regulatory Affairs Senior Specialist : At Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world. When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough At Johnson & Johnson Medical Devices Companies, we are using our breath, scale and experience to reimagine the way healthcare is delivered and to help people live longer, healthier lives. In a radically changing environment, we are making connections across science and technology to combine our own expertise in surgery, orthopedics and interventional solutions with the big ideas of others to design and deliver doctor and patient-centric products and solutions. We are hiring the best talent for Regulatory Affairs Senior Specialist to be located in LATAM (Relocation Not Applicable / Applicable). Purpose : Johnson & Johnson Medical Devices is recruiting for a Senior Regulatory Affairs Specialist, that can be located in multiple countries of Latin America. Are you motivated by working in a regional team? This person will lead the country assessments for Brazil and the Southern Cluster countries, as part of the centralized LATAM Change Hub. Responsibilities Review and assess change strategies to ensure accurate interpretation of country regulations, defining the most appropriate actions to be taken. Support change assessment implementation by helping define priority, planning schedule, and tracking submissions through completion. Accountable for the timely achievement of business goals and objectives, based on priorities and considering benefits / risks. Coordinate information on several projects simultaneously. Consistently handle changing, complex, and / or ambiguous information. Identify questions and coordinate clarification with the applicable partners. Lead and / or support process improvement and alignment with local, regional and global partners. Assist in the development and review of standard procedures. Qualifications Education : Bachelor\'s Degree in Engineering, Pharmacy, or other life sciences Experience and Skills : At least 5 years working in the regulatory environment (and / or training or equivalent combination of education and experience). Experience with Medical Devices and regulatory impact assessments is desirable, with clear preference for knowledge of regulations from Brazil and Southern Cluster countries (Argentina, Paraguay, Uruguay, Peru, Ecuador, and Bolivia). Advanced English is required; Spanish is desirable if not native speaker. Soft-skills that are aligned with J&J Credo; big picture orientation with attention to detail; data gathering and interpretation; drive to find information; ability to quickly acquire local knowledge and shift between situations; self-driven and require minimum supervision. Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Locations Primary Location Brazil-São Paulo-São Paulo Other Locations Latin America-Chile, Latin America-Ecuador, Latin America-Mexico, Latin America-Guatemala, Latin America-Peru, Latin America-Colombia, Latin America-Argentina Organization J&J do Brasil Indústria e Comércio de Produtos para Saúde Ltda. Job Function Regulatory Affairs Requisition ID #J-18808-Ljbffr