RRemoteville
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Quality and Regulatory Manager

Skills
Data EngineeringSoftware DevelopmentData ScienceMachine LearningMachine Learning AlgorithmsPattern Recognition
Role

What the job involves

The main requirements, responsibilities and hiring steps.

Requirements

  • Degree in Life Sciences, Biology, Engineering, or a related field required.
  • Minimum of 5 years of experience in a similar role within the biotech or medical device industry.
  • Strong technical acumen across software and biological/hardware products.
  • In-depth knowledge of relevant regulations like ISO 13485, ISO 14971, and ISO/IEC 62304.
  • Excellent project management, collaboration, and communication skills.

Nice to have

  • Machine Learning knowledge
  • Sequencing tech experience

Day to day

  • Ensure the highest standards of quality and regulatory compliance.
  • Implement and maintain a robust Quality Management System (QMS).
  • Lead the development of Technical Files for UKCA marking.
  • Manage regulatory submissions for various products and regions.
  • Collaborate on incorporating compliance in product design and development.