Especialista Sr de Asuntos Regulatorios

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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 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 hiring the best talent for a Regulatory Affairs Sr Specialist to be located in Bogota, Colombia (Relocation Not Applicable).

**Purpose**:
Responsible for facilitating the planning submissions of product approval documents within the filing requirements by acting as liaison between regulatory agencies and project team. Expedites approval processing by addressing issues in Colombia Central America & Caribe, ensuring compliance with government regulations and interpretations. Attend trade associations meetings.

**Key Responsibilities**:

- Examines plans for the submission of product approval documents. Reviews, evaluates, and compiles files and reports for submission.
- Develops 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.
- Resolves complex problems relating to licensing between the company and licensing regulators.
- Provides regulatory support and expertise across all functional areas involved in projects.
- Acts as liaison between regulatory agencies & trade associations, act as a project leader to expedite approval processing by addressing regulatory complexities.
- Compiles product approval packages. Prepares paper and electronic submissions.
- Participates and represents department at project meetings.
- Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with R&D and business objectives of the company, including consideration of the global regulatory environment.
- Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Being aware of and receptive to cultural differences across regions and countries.
- Serves as a technical expert within job function.

**Qualifications** Qualifications**:

- University/bachelor’s degree or Equivalent within a life science disciplines (Pharmacist, Biomedical Engineer, etc.)
- 4-6 years of experience working in Regulatory Affairs Environment.
- Intermediate level of English.
- Previous experience working in health industry (medical devices or Pharma) is a must.
- Multi country experience desirable.
- Demonstrated experience of managing multiple franchise projects simultaneously and consisting of varying degrees of complexity.

**Primary Location**
Colombia-Distrito Capital de Bogotá-Bogotá
- **Organization**
Johnson & Johnson de Colombia S.A. (7755)

**Job Function**
Regulatory Affairs

**Requisition ID**
2206059795W