Regulatory Affairs Sr Specialist

hace 1 semana


Ciudad de México Johnson & Johnson A 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 humans.

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 Move Could Mean Our Next Breakthrough.

At Johnson & Johnson Medical Devices Companies, we use our breadth, scale, and experience to reimagine how healthcare is delivered and help people live longer, healthier lves.

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 in this for life.

We are changing the trajectory of human health, YOU CAN TOO.

**We are searching for the best talent for Regulatory Affairs SR Specialist to be in Ciudad de México.**

**Purpose**:Responsible for facilitating the submission of product approval documents within the filing requirements by acting as a liaison between regulatory agencies and the project team. Expedites approval processing by addressing issues and ensuring compliance with government regulations and interpretations

**You will be responsible for**:

- Develops appropriate plans for the submission of product approval documents to ensure rapid and timely approval of 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 and project teams to expedite approval processing by addressing complicated issues.
- Compiles complex product approval packages. Prepares paper and electronic submissions.
- Participates and represents the department at project meetings.

**Qualifications**:
**Qualifications and requirements**:
**Functional and Technical Competencies**:

- 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.
- Is aware of and receptive to cultural differences across regions and countries.
- Serves as a technical expert within the job function
- Strong organizational skills
- Project management skills
- Problem-solving skills
- Presentation skills
- Fulfills competencies stated in the RA Global Competency Model as follows:

- Applied Technical Knowledge - Leading
- Business Acumen - Applying
- Decision Making & Prioritization - Applying
- External Focus - Applying
- Leading and Influencing - Applying
- Persuasive Communication - Applying
- Bilingual: Spanish - English 80%

**Leadership Competencies**:

- Connect - Be insight driven to uncover unmet needs, and effectively influences others by partnering with them.
- Shape - Translates insights into viable processes and solutions that create value
- Lead - Demonstrates conviction, proactivity, and persistence when influencing others and overcoming resistance; gains support for one’s perspectives and ideas by establishing clear, positive links between ideas and business needs
- Deliver - Manages complex projects independently

**EDUCATION & EXPERIENCE REQUIREMENTS**:

- University/bachelor’s Degree or Equivalent within a technical-related discipline.
- 4-6 years of related experience. Can be a person with related experience and/or training or an equivalent combination of education and experience, including a master’s degree.



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