Senior Regulatory Specialist

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