Regulatory Affairs Specialist- Colombia/Panamá
hace 3 semanas
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at .
DE&I Statement For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.
Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve.
Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
We are searching for a Regulatory Affairs Specialist to be in Bogotá, Medellín, Cali, Cartagena, Barranquilla - Colombia, or Panama City - Panama.
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.
Responsible for supporting strategies for efficiencies in the regulatory activities.
You will be responsible for: Execute plans for the submission of product approval documents to ensure rapid and timely approvals for medical devices and maintain the approved status of marketed medical devices.
Provide support in implementing strategies that enhance efficiency in regulatory activities.
Participate in and represent the department at project meetings following management directions.
Qualifications: Related experience (3-5 years) and/or training or equivalent combination of education and experience in health science, 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 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.
UDI knowledge is highly desirable.
Data management skills are highly desirable.
Proficient in the usage of Power BI, development of apps is highly desirable.
Experience with artificial intelligence tools.
English proficiency at 80%.
Strong abilities in MS Office.
Skills: 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 for low complexity projects within job function.
Strong organizational skills.
Project management skills.
Problem-solving skills.
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