Regulatory Affairs – Netherlands
Full Time
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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 compliance.
- Review and approve product labeling to ensure compliance with global regulatory requirements.
- Support and participate in inspections and audits conducted by global regulatory authorities.
Responsibilities
- Minimum 5 years of Experience
- Fluent English
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [email protected]
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