Head of Regulatory Affairs

2 months ago


Kent, United Kingdom SciPro Full time

This company is a household name and is a well-established consumer goods company, based out of the US/UK/Europe. They are searching for a Head of Regulatory to act as their EU point of contact and lead a team of regulatory professionals across EU/UK.


Responsibilities:

  • Act as a liaison between UK/EU management and the Quality, QA Manufacturing, and Regulatory departments.
  • Oversee the development and management of regulatory documents, including technical files and dossiers.
  • Provide strategic guidance on EU regulatory compliance for medical devices and pharmaceuticals.
  • Manage project assignments related to investigational, new, and marketed products.
  • Support third-party and competent authority audits.
  • Gather regulatory intelligence from government agencies and trade associations.
  • Communicate the impact of regulatory changes to the business and global partners.


Requirements:


  • In-depth knowledge of legislation for Medical Devices across Europe is mandatory
  • Experience with cosmetics, Pharmaceuticals, Electrical products, Food supplements, or detergents would be beneficial
  • Familiarity with MDR, MDSAP, OTC, EU Reg 1223/2009, and Quality Management Systems (ISO 22716, ISO 13485, ISO 9001)
  • Experience with French language would be a plus
  • Experience liaising with regulatory bodies and able to work cross-functionally


Please apply now to be considered for the initial shortlist.



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