Job Summary
We are looking for Lead Product Test Consultant with a focus on document and validate software installed on medical laboratory instrumentation according to EMA guidelines.
Responsibilities
Document and validate software installed on medical laboratory instrumentation according to EMA guidelines.
Lead the development and execution of comprehensive test strategies for regulatory compliance projects.
Provide expert guidance on compliance management and regulatory affairs operations.
Document software specifications Create infrastructure diagrams and Create data flow diagrams
Perform risk assessments
Collaborate with cross functional teams to ensure seamless integration of compliance requirements.
Develop and maintain documentation for testing processes and compliance standards.
Ensure timely delivery of testing milestones and compliance reports.
Facilitate communication between stakeholders to address compliance related concerns.
Implement best practices for testing and compliance management to enhance efficiency.
Support the training and development of team members in compliance testing methodologies.
Contribute to the continuous improvement of testing frameworks and tools.
Drive the adoption of innovative testing solutions to meet evolving regulatory requirements.
Write validation test cases and document software specifications
Certifications Required
Optional
