Regulatory Affairs Specialist (S263)
- Argentina
- Permanente
- Tiempo completo
At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity.Diversity & Inclusion are crucial to continue building our history of groundbreaking 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 Move Could Mean Our Next Breakthrough.At Johnson & Johnson Medical Devices Companies, we are using our breadth, scale, and experience to reinvent 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 craft and deliver doctor and patient-centric products and solutions.We are in this for life.We are changing the trajectory of human health, YOU CAN TOO.**We are hiring the best talent for REGULATORY AFFAIRS SPECIALIST to be located in Argentina (Relocation Not Applicable).*****:**Purpose**:
As a RA Specialist you will be responsible for strategies and plan execution of our portfolio. We are looking for an up-to-date professional who can help us!**Main responsibilities:**:Actively participation and timely delivery results in RA teams to achieve common goals or attend common strategies.Prepares common registration dossiers for new products' introduction, new product development, product changes and renewals.Reviews and assesses documentation to ensure accurate interpretation of country regulations.Supervise and analyze country requirements to identify trends/changes in regulation.Consults with other stakeholders within the organization regarding submission requirements and standards to facilitate efficient processing by health authorities in multiple countries.Integrates and executes results-oriented Regulatory Affairs strategies. Accountable for the achievement of business goals and objectives, based on priorities and considering benefits/risks.Consistently handles large amounts of changing, sophisticated, and/or ambiguous informationAssists in the development of best practices for Regulatory Affairs processesSupport change assessments implementations by planning schedules for regulatory deliverables, supervising submissions through completion.Coordinate information on several projects simultaneously.Ensures compliance with governmental regulations and interpretations.**Qualifications**
**Qualitifications:**:**Education Requirements**:A Bachelor’s Degree or career on process in Engineering, Pharmacy or other life science: Can be a person with related experience and/or training or equivalent combination of education and experience.Languages: English (intermediate) - local language (Spanish)Experience: Must have 1-3 years experience at least working in Regulatory Environment (and/or training or equivalent combination of education and experience), preparing submissions for sophisticated devices and a successful track record. Desirable experience in Medical Devices. Pharma background is acceptable.**Knowledge**:- Sophisticated PC skills
- Knowledge in Argentinian Regulation and Processes; previous experience in dossier creation desirable.**Capabilities**:- Prioritizes work to meet deadlines
- Communicates clearly, succinctly, and effectively.
- Planning and Organizing skills
- Understands the importance of the adherence to compliance
- Analytical capabilityTravel %: 0%**Reports to: RA Lead Specialist**:
**Base location: Bogota, Colombia**
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.**Want to be part of something great?****Don't forget to apply. We want you!****Primary Location**
Argentina-Buenos Aires-Villa Adelina
- **Organization**
Johnson & Johnson Medical S.A. (7435)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206033534W
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