Regulatory Affairs Specialist
4 days ago
A dynamic and innovative medical device company, X4 Life Sciences, is seeking a highly motivated Regulatory Affairs Specialist to support their growth.
Job Description:The ideal candidate will oversee the development and management of technical files, dossiers, and regulatory documents for medical devices and pharmaceuticals. This includes providing regulatory guidance and support, ensuring compliance with EU regulations, and assisting in third-party audits.
Responsibilities:- Develop and implement EU regulatory strategies, ensuring products meet all necessary requirements.
- Manage project assignments for investigational, new, and marketed products.
- Liaise with government agencies and gather regulatory intelligence.
- More than 7 years' experience in regulatory affairs, ideally gained within a Medical device business.
£90,000 - £110,000 per annum.
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