.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