Stryker
Descripción
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.
