What to Expect

• Establish and manage regulatory submission timelines for both new and existing products across key global markets
• Prepare and file global medical device applications and amendments, ensuring timely market access.
• Engage with regulatory authorities and distribution partners to support product registrations
• Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
• Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directives to ensure ongoing global ...