Regulatory Affairs Specialist

hace 2 semanas

Bogotá, Bogotá D.E., Colombia 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 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 Move Could Mean Our Next Breakthrough.


At Johnson & Johnson MedTech Companies, we are using our breadth, 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 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 Specialist to be in Bogotá.

Purpose:
Responsible for executing 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

You will be responsible for:

  • Executes 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 stakeholders according to management directions.
  • Participates and represents the department at project meetings according to management directions.

Qualifications:

Qualifications and requirements:

  • Bachelor's degree with related experience and/or training or equivalent combination of education and experience, including a master's degree
  • Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations, and guidance, to prepare compliant Regulatory strategies aligned with the company's R&D and business objectives, 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 resultsoriented 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 lowcomplexity projects within the job function
  • Strong organizational skills
  • Project management skills
  • Problemsolving skills
  • English 80%
  • Strong abilities in MS Office

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