Key Responsibilities:

•  Leading regulatory strategy and submission processes for medical devices and combination products, ensuring compliance with MDR, IVDR, and other regulations.
• Providing regulatory expertise in the development of companion diagnostic projects, from early development stages to product launch.
• Advising clients on regulatory requirements for Laboratory Information Management Systems (LIMS), ensuring data integrity and system validation meet current standards.
• Preparing and submitting regulatory dossiers for combination products that integrate medical devices and pharmaceuticals.
• Ensuring compliance with global regulatory frameworks, including FDA, EMA, and other international authorities.
• Providing guidance on post-market surveillance and risk management for medical devices.
• Leading regulatory efforts throughout the product lifecycle, from R&D to commercialization, across various device types.
• Collaborating with cross-functional teams, such as R&D, Quality Assurance, and Marketing, to provide strategic regulatory insights.
• Staying current on global regulatory changes to ensure all client projects meet evolving compliance requirements.