Job Description
Cure Talent are delighted to be partnered with an exciting Diagnostics company, specialising in Gastrointestinal Cancer, who, due to their continued growth, have an exciting opportunity for an experienced Regulatory Affairs Specialist to join their dedicated team.
This role will primarily focus on Regulatory Affairs, supporting the preparation and maintenance of regulatory submissions, risk management, and ensuring compliance with relevant standards such as ISO 13485, MDR, and IVDR. It will also include limited Quality Assurance responsibilities focused on QMS maintenance and audit support.
The ideal candidate will have strong regulatory knowledge, experience preparing technical documentation, and familiarity with risk management and post-market surveillance processes. Effective communication skills and the ability to work cross-functionally are essential.
Key Responsibilities:
1. Support the preparation and maintenance of regulatory submissions, including Technical Files and Design Dossiers
2. Assist with clinical study documentation, risk management, and reports
3. Maintain knowledge of ISO 13485, MDR, and IVDR requirements
4. Provide support for new product development and registration activities
5. Maintain Risk Management Files, PMS reports, and labelling requirements
6. Assist in internal audits and support audit preparation