Our client is an established medical device company operating worldwide to enhance patient outcomes with leading innovative medical devices. They are headquartered in the UK with a global network of subsidiaries supporting over 105 countries.
They manufacture a variety of medical devices and are looking to make a difference to patients working with clinicians around the world.
They are in the process of expanding the QARA team and looking to add a Senior Regulatory Affairs Specialist. This role could be site based, hybrid or remote working for those further away.
Responsibilities:
The Senior Regulatory Affairs Specialist will assist in the company's transition to EU MDR
Maintaining Technical files (Class Is, IIa or IIb) medical devices and technology
Provide inputs into key Design and Development projects
Assist the team in delivering key regulatory documents
Review and approval of relevant design changes inline with EU/FDA guidance
Contribute to SME topics during external audit
Assist partners with key documents for ext. registrationsQualifications:
Ideally degree level education or equivalent practical work experience in Regulatory Affairs
History with medical devices
Knowledge of ISO 13485
Expertise with Urology or Respiratory Devices (although this is not a deal breaker)To find out more about Real, please visit