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Lead Regulatory Affairs Specialist

3 months ago

Guildford, Surrey, United Kingdom Singular: Building Brilliant Biotechs Full time
Position Overview

Lead Regulatory Affairs Specialist // Biotechnology Sector

Are you prepared to spearhead regulatory strategies and ensure compliance for pioneering cancer diagnostic solutions?

Join a dynamic biotechnology firm that is revolutionizing cancer diagnostics through innovative liquid biopsy technology. We are seeking a Lead Regulatory Affairs Specialist to enhance our team.

Your Role

In this pivotal position, you will play a crucial role in maintaining regulatory compliance and propelling our cutting-edge technology forward. You will work closely with research and development, clinical, and commercial teams to facilitate new product initiatives and international regulatory submissions.

Key Responsibilities

  • Team Leadership: Supervise the Regulatory Assistant and coordinate efforts with internal departments.
  • Strategic Contributions: Provide insights into regulatory strategy and planning to meet project objectives.
  • Study Oversight: Design and manage analytical and clinical verification/validation studies.
  • Regulatory Filings: Collaborate with regulatory bodies to prepare and submit device registration documentation.
  • Post-Market Monitoring: Oversee surveillance activities to fulfill regulatory obligations.
  • Compliance Assessment: Evaluate product promotional materials and external communications for regulatory adherence.
  • Quality Assurance: Assist in maintaining the ISO13485 quality management system and securing quality certifications.

What We Provide

  • Innovative Atmosphere: Become part of a team dedicated to groundbreaking cancer diagnostic technologies.
  • Professional Development: Acquire valuable experience in a leading biotechnology firm, with opportunities for career advancement.
  • Collaborative Environment: Join a team that prioritizes innovation, teamwork, and shared success.

Are You the Ideal Candidate?

Do you possess experience in medical device product development and a comprehensive understanding of global medical device regulations? Are you meticulous and adaptable in your approach?

Qualifications and Skills:

  • Experience with ISO 14971 and medical device product development.
  • Demonstrated success in developing regulatory pathways and securing global approvals.
  • Thorough knowledge of international medical device directives, regulations, and standards.
  • Highly detail-oriented with the ability to manage multiple projects concurrently.

Position Requirements:

This role offers flexibility for remote work, with potential travel to various sites as needed.

If you are eager to contribute to advancements in cancer diagnostics, we encourage you to consider this opportunity.