Validation and Compliance Specialist

1 month ago


Dartford, Kent, United Kingdom DiaSorin Full time
Validation and Compliance Specialist

At DiaSorin, we're committed to delivering innovative healthcare solutions that make a meaningful difference in the world. As a Validation and Compliance Specialist, you'll play a critical role in ensuring our products and processes meet the highest standards of quality and regulatory compliance.

Key Responsibilities:
  • Lead and coordinate the Site Validation Review Board, overseeing the implementation of the S-VMP.
  • Develop, execute, and maintain validation protocols and reports for all manufacturing processes in accordance with ISO 13485 and IVDR regulations.
  • Validate and verify analytical and testing methods to ensure they are suitable for their intended use, producing reliable and reproducible results.
  • Conduct validation of spreadsheets used for data handling and analysis to ensure accuracy and compliance with regulatory standards.
  • Contribute to project Cross Functional Teams (CFTs) as a Validation subject matter expert, ensuring adherence to validation policies, procedures, safety, and training.

Requirements:
  • Strong background in validation processes, quality systems, risk management, and regulatory compliance within the medical device or IVD sector.
  • IVDD/IVDR compliance knowledge advantageous.
  • Familiarity with risk management principles and practices in a regulated environment.
  • Managing timelines and prioritizing workload to meet business needs.

About DiaSorin:

DiaSorin is a global leader in the diagnostic industry, committed to delivering innovative healthcare solutions that make a meaningful difference in the world. We're passionate about innovation, diversity, and making a positive impact on healthcare. If you're looking for a challenging and rewarding career, join our team and be part of our mission to improve patient care and outcomes.
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