Cure Talent are delighted to be partnered with a medical device manufacturer as they look to strengthen their Regulatory Affairs capability. We have an exciting opportunity for a Regulatory Affairs Specialist to join an established regulatory team and take ownership of technical documentation and international registration activities for complex medical devices.
As the new Regulatory Affairs Specialist, you will play a central role in the creation and maintenance of Technical Documentation, ensuring compliance with EU MDR and global regulatory requirements. This is a hands-on position requiring detailed knowledge of GSPR requirements, regulatory justification and structured documentation development. You will work closely with the Regulatory Affairs Manager and cross-functional stakeholders to support ongoing registrations, product extensions and expansion into new international markets.
Key Responsibilities
- Author and maintain Technical Documentation and Design Dossiers in line with EU MDR requirements.
- Develop and manage GSPR mapping, ensuring clear demonstration of regulatory compliance.
- Support global product registrations and lifecycle maintenance across EU, LATAM and emerging markets.
- Contribute to regulatory activities for new product development and product range extensions.
- Support audit activities and interactions with Notified Bodies and regulatory authorities.
- Review labelling, promotional materials and regulatory submissions to ensure compliance.
- Prepare and coordinate Rest of World submissions following internal review and approval.
Experience and Skills Required
- Experience authoring Technical Documentation within a medical device regulatory environment.
- Strong understanding of EU MDR requirements and GSPR fulfilment.
- Experience supporting or participating in regulatory audits.
- Knowledge of international registration processes beyond the EU is advantageous.
- Exposure to custom-made or distributed medical devices would be beneficial.
- FDA or PMA experience would be highly advantageous but is not essential.
- Strong attention to detail and ability to work confidently with technical stakeholders.
If you are a Regulatory Affairs professional with genuine depth in Technical Documentation and want to play a key role in global regulatory delivery within a growing medical device organisation, we would welcome a conversation.