Providing strategic registration direction on interaction and negotiating evidence with regulatory agencies. Serving as a regulatory liaison on the project team…
_Experience in quality management and regulatory affairs in the field of medical technology_. Übernahme des Qualitätsmanagements, inkl. der Funktion des QMB.
Ensure that all IT products are compliant with internal security, risk management policies and practices, external regulatory and statutory requirements.
Work in collaboration across the regulatory organization with stakeholders (such as the global regulatory lead (GRL) and the country regulatory lead (CRL) to…
Develop and implement regulatory required processes. Partner with global RA functions to ensure new regulatory requirements are collected and analyzed.