Especialista De Asuntos Regulatorios

Envista

Not specified
Cofepris regulatory submissions
Ministry of health registration planning
Nom 137 product labeling compliance
Envista is seeking a Regulatory Affairs Specialist responsible for overseeing medical device registration projects, including submissions to the Ministry of Health in Mexico and managing license approvals and modifications. The role requires expertise in regulatory compliance and project management, as well as effective communication with various stakeholders

Job Summary

  • The role is responsible for overseeing the planning of registration projects including budgeting and obtaining approvals from the Ministry of Health.
  • Candidates must stay updated on every regulatory change applicable to medical devices in Mexico and manage appointments with COFEPRIS.
  • The position involves supporting registration projects across LATAM by preparing documentation and reviewing translations required by distributors.

Matching Summary

Match Score: 85

Envista is seeking a Regulatory Affairs Specialist responsible for overseeing medical device registration projects, including submissions to the Ministry of Health in Mexico and managing license approvals and modifications. The role requires expertise in regulatory compliance and project management, as well as effective communication with various stakeholders.

Skills & Requirements

Must-have

  • COFEPRIS regulatory submissions
  • Ministry of Health registration planning
  • NOM 137 product labeling compliance
  • Technovigilance report management
  • Import permit processing

Nice-to-have

  • LATAM regional project experience
  • Cross-functional team collaboration
  • Manufacturer document coordination

Key Requirements

  • Experience with Mexican medical device regulations
  • Knowledge of NOM 137 labeling standards
  • Ability to manage COFEPRIS interactions

Work Rights

Not specified

Tailored Resume

Cover Letter