Regulatory Affairs – United Kingdom
Job Description
What to Expect
- Establish and manage regulatory submission timelinesfor 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 partnersto 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 assessmentsfor 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 directivesto ensure ongoing global compliance.
- Review and approve product labelingto ensure compliance with global regulatory requirements.
- Support and participate in inspections and auditsconducted by global regulatory authorities.
Requirements
- 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) or email
Tagged as: Regulatory Affair
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