Regulatory Affairs Specialist

Regulatory Affairs Specialist – Medical Device

Xplore Life Science is recruiting for a Regulatory Affairs Specialist. This role is ideal for someone who is looking to join a team that is responsible for collecting, evaluating, organising, communicating, and understanding of information relating to regulatory requirements for new and existing products.

This is a freelance role with immediate start
Hybrid Remote working is possible with offices in Cambridge.

Responsibilities

• To ensure that the business goals are achieved in a timely and efficient manner
• Participate in project teams to provide regulatory input into cross departmental product development and international registration projects
• Independently create and maintain product technical files and product design
• Prepare documentation and product registration dossiers to support global regulatory submissions.

Requirements

• Minimum 2 years’ experience working in Regulatory Affairs ideally within medical devices but would consider pharma or biocidal industries
• Understanding of regulatory requirements where the company markets its products Globally, including EU, UK, APAC, USA
• The ability to work on own initiative within the remit of the role

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