Global Regulatory Affairs Specialist – Medical Devices

Cure Talent; East Hagbourne; On-site; GBP 40,000 - 55,000; Full time

Job summary

A medical device company in East Hagbourne is seeking a Regulatory Affairs Specialist. This role involves supporting worldwide product registrations and working closely with teams across Sales and Marketing. The ideal candidate will have experience with Class III medical devices and regulatory compliance. Responsibilities include maintaining technical documentation and ensuring compliance with applicable regulations. If you are looking to grow within a collaborative environment focused on international market access, we encourage you to apply.

Qualifications

• Experience working in a Regulatory Affairs support role within a medical device company.
• Knowledge and experience working with Class III medical devices.
• Strong understanding of regulatory frameworks applicable to Class III devices.

Responsibilities

• Support worldwide product registration submissions and ongoing maintenance activities.
• Assist with new product registrations across international markets.
• Maintain Design Dossiers and Technical Files in line with regulatory requirements.
• Ensure compliance of labelling and promotional materials.

Skills

Regulatory Affairs experience

Class III medical devices knowledge

Technical documentation maintenance

Communication with technical stakeholders

Regulatory frameworks understanding

Job description

A medical device company in East Hagbourne is seeking a Regulatory Affairs Specialist. This role involves supporting worldwide product registrations and working closely with teams across Sales and Marketing. The ideal candidate will have experience with Class III medical devices and regulatory compliance. Responsibilities include maintaining technical documentation and ensuring compliance with applicable regulations. If you are looking to grow within a collaborative environment focused on international market access, we encourage you to apply.