Regulatory Affairs Strategist

12 hours ago


London, Greater London, United Kingdom X4 Life Sciences Full time

A highly experienced Regulatory Affairs Strategist is needed to develop and implement EU regulatory strategies for medical devices at X4 Life Sciences, a growing London-based company. This role oversees the management of technical files, dossiers, and regulatory documents.

About the Role
  • Work closely with Notified Bodies to obtain FDA and FDR approval for products.
  • Provide regulatory guidance and support to ensure EU regulation compliance.
  • Liaise with government agencies and gather regulatory intelligence.

This position requires more than 7 years' experience in regulatory affairs, preferably in a medical device business, with expertise in MDR, ISO13485, and UK MDR regulations.

The estimated salary for this role is £95,000 per annum, depending on experience.



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