Responsibilities: Ensure the lab instruments are calibrated prior to performing IQ/OQ and certify. Produce GxP documentations for the instrument software validation. Own change controls and deviation management. Prepare and execute IQ/...
Responsibilities: Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. Works with ...
Responsibilities: Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing. Assist in keeping company informed of regulatory requirements in the US and EU. Participate on ...
Responsibilities: Responsible for regulatory activities, including product registrations, regulatory impact assessment, etc. Understand country-specific requirements and deliver those to internal stakeholders, including product managemen...