Regulatory Affairs Specialist

hace 1 semana

Ciudad de México, Ciudad de México Abbott A tiempo completo

The Opportunity

We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people. Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

As the Regulatory Affairs (RA) Specialist, you'll be responsible to coordinate and manage all related RA local activities for the Abbott Toxicology portfolio in LATAM RA local regional team.

What You'll Do:

Support and develop regulatory submission plan for LATAM regions in collaboration with the Legal Manufacture (LM)-RA INT Manager, LM-RA INT team, project team, supply chain or applicable stake holders. Shape and support innovative regulatory strategy for new product introduction, pre-market registrations and execute change notification amendment registrations to support product life cycle management as per business needs. Evaluate the type of regulatory process applicable per product based on LM-RA proposal and COMM needs. Confirm to LM-RA the registration requirements, labeling/translation requirement, and estimated times for each process. Work closely with LM-RA INT team and other functions to obtain all the necessary documents to support local country product registration, renewal or amendment to existing product certificates. Rreview documents provided by LM-RA Follow up on dossier preparation and additional local procedures Coordinate applicable local translations and review them. When applicable, submit the Dossier on the electronic system and provide copy of final submission provided to local MoH and proof of submission date to LM-RA Ensure timely execution of regulatory strategies as per plan. Collaborate with LM-RA INT team to track regulatory milestones in internal Regulatory database. Report submission status via defined Key Performance Indicators. Reports on the authorization or denial of each regulatory procedure. Represents RA locally at relevant in country meetings in collaboration with LM-RA INT team. Responsible for review of promotional material for the applicable regions. Support Abbott strategic Quality and Regulatory Affairs Goals and objectives. Monitor developing regulations and gather regulatory intelligence that may be relevant to the business. Conduct impact assessment and disseminate as appropriate to key stakeholders. Coordinate Legalizations, when applicable Ensure warehousing activities to be align with approvals. Keep up to date the tracking's and data's Support and collaborate with RA country teams on the surveillance activities

Required Qualifications

BSc or equivalent. A minimum of 3 years experience in Regulatory Affairs in Medical Devices, ideally in IVDs Demonstrable working knowledge of the medical diagnostics industry, including non-IVD products. Demonstrated capacity in project management. Able to navigate in a cross functional environment . Knowledge of the regulatory regulations and environment in key countries IVD medical device regulations e.g. ASEAN Medical Device Directive, US FDA, EU IVDD/IVDR regulatory environment, legislation, industry standards and guidance and digital health product regulations and requirements. Strong knowledge of ISO 13485 and GDPMD requirements. Excellent written and oral communication skills in English/Spanish Attention to detail. Strong interpersonal skills. Highest levels of integrity and diplomacy. Capacity to maintain the highest levels of confidentiality internally and externally.

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