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Regulatory Affairs Process Specialist
hace 2 semanas
**Regulatory affairs 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 SPECIALIST to be located in BOGOTA (Relocation Not Applicable / Applicable).
**Purpose**:
Responsible for performing the submission process of product approval documents within the filing requirements. Expedites approval processing by addressing issues and ensuring compliance with government regulations and interpretations
**Key Responsibilities**:
- Implements appropriate plans for the submission of product approval documents to ensure rapid and timely approval on medical devices and continued approved status of marketed medical devices.
- Provide support as POC for internal collaborators according to strategic directions.
- Participates and represents department at project meetings according to strategic directions.
**Qualifications**
**Qualifications and Requirements**:
Professional en chemistry, biology or life sciences careers with 2 or shown experience working in RA in Medical devices.
- Demonstrates a proven understanding of the regulatory environment, including compliance, current and proposed laws, regulations and mentorship, to prepare compliant Regulatory strategies that are aligned with R&D and business objectives of the company, including consideration of the global regulatory environment. Completes Regulatory strategies in compliance with relevant laws, regulations, and interpersonal requirements vital to acquire, and maintain, legal market status.
- Demonstrates the ability to give to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Is aware of and receptive to cultural differences across regions and countries.
- Serves as a technical expert for low complexity projects within job function
- Strong interpersonal skills
- Project management skills
- Problem solving skills
- English 80%
- Strong abilities in MS Office
**Primary Location**
Colombia-Distrito Capital de Bogotá-Bogotá
- **Organization**
Johnson & Johnson de Colombia S.A. (7755)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206040446W
