Location(s): Mexico City, Mexico City, Mexico ⋅ Mexico City, Mexico
Experience Level(s): Senior
Field(s): Legal & Compliance
Work Flexibility: Hybrid
What you will do-
Coordinate the annual submission plan for new product registrations and renewals, aligning plans with COFEPRIS requirements and contributing to their development. Also, responsible for handling specific or challenging demands.
Lead and manage a team of three individuals overseeing medical equipment regulatory submissions to COFEPRIS in Mexico.
Conduct monthly meetings with AMID and engage with regulatory affairs counterparts in other Latin American countries, the US, and production facilities.
Oversee the regulatory submission process for medical devices, ensuring compliance with COFEPRIS guidelines and maintaining contact with manufacturing plants.
Collaborate cross-functionally to align regulatory strategies with product development and commercial goals, ensuring adherence to regulatory standards.
Participate in the creation and enhancement of regulatory submission plans, adapting to evolving regulatory requirements.
Supervise, guide, and provide direction to the regulatory affairs team, ensuring their professional growth and development.
Maintain a comprehensive understanding of medical device regulatory standards and updates, applying them to enhance registration processes and submissions.
What you will need-
Previous experience in similar positions, working in Medical Devices companies, required.
Bachelor’s Degree required.
Advanced English skills required.
Previous experience in management positions required.
Participation in COFEPRIS associations required.
Azure DevOps (ADO) and Power BI expertise desired.