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 external registrations. Qualifications:
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).
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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 external registrations. Qualifications:
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).
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