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Regulatory Compliance Specialist

2 months ago

Cambridge, Cambridgeshire, United Kingdom Reed Full time

Job Summary

We are seeking a highly organized and detail-oriented Regulatory Compliance Specialist to join our team at Reed. As a key member of our regulatory affairs department, you will play a critical role in ensuring the smooth operation of our product compliance functions.

Key Responsibilities

  • Regulatory Support
    • Prepare and submit regulatory documents, including applications, registrations, and reports, and maintain an organized and up-to-date database of regulatory documents, approvals, and correspondence.
  • Administrative Tasks
    • Draft and format regulatory documents, letters, and other correspondence.
  • Product Support
    • Provide technical support to external partners and customers by responding to inquiries or complaints in line with regulatory guidelines.

Qualifications and Experience

  • Bachelor's degree in a Life Science related field
  • 2 years of experience in a regulatory, compliance, or product support environment, with a basic understanding of regulatory requirements for medical device software development (e.g., ISO)
  • Strong organizational skills and attention to detail.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and document management systems.
  • Excellent communication skills, both written and verbal.

About the Role

This is an exciting opportunity to join a leading company in the biotech industry and contribute to the development of innovative products that make a difference in the field of diabetes management.