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Full-Time Opportunity: This is a permanent, full-time position with a competitive package and real career growth potential.
Job Description
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 ...