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Medical Device Registration Specialist

hace 2 semanas

Ciudad de México, Ciudad de México Boston Scientific A tiempo completo

We are seeking a highly skilled Regulatory Affairs Specialist I to join our team in Mexico. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices.

About the Position:

The ideal candidate will have a solid understanding of COFEPRIS rules and regulations, as well as experience in managing sanitary registrations and import permits. You will work closely with internal teams and health authorities to ensure timely approvals and maintenance of necessary health authorizations.

Key Responsibilities:
  • Ensure compliance with regulatory requirements
  • Manage sanitary registrations and import permits
  • Maintain relationships with health authorities and internal teams
Requirements:
  1. Bachelor's degree in a related field (pharmaceutical chemist, biomedical engineering, biological sciences)
  2. 1-3 years of experience in regulatory affairs for medical devices
  3. Solid knowledge of COFEPRIS rules and regulations