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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. 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)
To find out more about Real, please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy | Registered office |8 Bishopsgate, London, EC2N 4BQ, United Kingdom | Partnership Number | OC387148 England and Wales
