Quality and Regulatory Expert

1 month ago


Bromborough, Wirral, United Kingdom Hunter Selection Full time
Job Title: Quality and Regulatory Specialist

We are seeking a highly skilled Quality and Regulatory Specialist to join our QA department. As a key member of our team, you will play a crucial role in ensuring the effectiveness of our Quality Management system.

Key Responsibilities:
  • Collaborate with the Quality Assurance Manager to maintain compliance with all applicable Quality standards, regulatory, and statutory requirements.
  • Provide support and advice to Company departments on regulatory and quality assurance matters.
  • Assist in maintaining compliance with ISO 13485 and ISO 9001 standards.
  • Ensure that all required aspects of business Quality Management Systems are implemented, controlled, and managed in accordance with applicable International Quality Management standards.
  • Work with Research and Development, and Quality Control staff to compile, store, and make accessible product technical documentation in accordance with applicable regulatory requirements.
Requirements:
  • Understanding of Quality Management Standards (ISO 13485 and ISO 9001) and/or 'Medical device' regulatory affairs.
  • Life Science or related degree: Pass grade or above.
  • Knowledge and understanding of diagnostic microbiology and diagnostic products.
  • Experience of formal techniques of problem solving such as Risk based thinking, corrective and preventative actions, root cause analysis.
About Us:

We are a market leader in our industry, with a strong presence across the UK. We offer a stable and secure career for technically motivated engineers. If you are interested in this position, please click 'apply' to submit your CV/resume.



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