Regulatory Affairs Specialist
hace 2 meses
Unlock your career aspirations and grow with Abbott Laboratories, a global healthcare leader.
We're looking for a talented Regulatory Affairs Specialist to join our team in Mexico City. As a key member of our Regulatory Affairs department, you'll play a crucial role in ensuring compliance with regulatory requirements for our medical devices portfolio in Latin America.
About the Role:
As the Regulatory Affairs Specialist, you'll be responsible for coordinating and managing all local RA activities for the Abbott Toxicology portfolio in LATAM. This includes requesting technical and legal documentation from our corporate office, preparing and submitting Health Registration dossiers, and interacting with various departments to ensure product availability.
Key Responsibilities:
- Request and prepare Health Registration dossiers through different submission channels
- Submit and collect paperwork at COFEPRIS, ensuring compliance with sanitary and regulatory requirements
- Interact with Quality Control, Marketing, Logistics, Government, Sales, Warehousing, and Customs teams to avoid importation and tender process issues
- Update databases of records, advertisements, technovigilance, contracts, and suppliers
- Prepare and submit product evaluation files to InDRE
Requirements:
- Minimum 5 years' experience in Regulatory Affairs for Medical Devices, preferably in IVDs
- University-level studies with a degree and professional license in health-related areas
- Knowledge of Medical Device Regulation LGS, RIS, RLGS in Advertising, FEUM, NOM 137, NOM 240, NOM 241
- Advanced level English language skills
- Excellent organizational and communication skills
What We Offer:
- A competitive salary: $60,000 - $80,000 per year
- A dynamic work environment with opportunities for growth and development
- A comprehensive benefits package, including health insurance, retirement plan, and paid time off
- The chance to work with a global healthcare leader and make a meaningful impact on people's lives
About Us:
Abbott Laboratories is a global healthcare leader that creates breakthrough science to improve people's health. We're committed to innovation, quality, and excellence in everything we do. Join our team and discover a career that matters.
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