Medical Diagnostics Specialist

1 week ago

Sydney, New South Wales, Australia beBeeMolecular Full time $120,000 - $175,000
Validation Manager

As a key member of our team, you will be responsible for leading studies for domestic and international regulatory submissions, facilitating the company's innovative molecular diagnostics technology to market.

The Validation Manager will oversee a team of professionals in performing validation studies, ensuring that all products meet rigorous standards. Key responsibilities include:

  • Drafting validation protocols and planning study execution
  • Decision-making on troubleshooting, analytical/clinical validation studies, and variables
  • Collaborating with Regulatory Affairs on drafting analytical and clinical validation protocols
  • Assisting scientists with analytical studies for new nucleic acid extraction kits and real-time PCR assays
  • Supporting process, equipment, and computer software validation
  • Analyzing data and assisting with problem-solving and experimental design
  • Preparing validation and clinical trial reports with Regulatory Affairs
  • Performing product validation studies and recording evaluations
  • Conducting controlled validation experiments (e.g., specificity, sensitivity, and stability studies)

Requirements and Qualifications

To succeed in this role, you will need:

  • A scientific background with a Bachelor of Science or Biomedical Science; a Master's or PhD is desirable
  • Experience in product, process, or equipment validation of medical devices to FDA regulations
  • Familiarity with molecular biology products, including real-time PCR
  • A strong understanding of the molecular diagnostics field and relevant international regulations
  • Leadership experience in managing highly educated professionals

About This Opportunity

This is an excellent opportunity to work in a dynamic and innovative field, driving cutting-edge technologies to enhance patient care.

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