Associate Manager, Regulatory Affairs (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.