Responsible for reviewing technical documents and EU declaration of Conformity with MDD, MDR and IVDR and communicated the identified non-conformity to affected legal manufacturers or business units for submission of missing documents or provision of missing information to ensure compliance to obligatory quality and regulatory standards and policy.
Reviewed CE and DE certificates to ensure validity and conformity with applicable regulatory and quality standards.
Collaborated with teams to review and update regulatory trackers to ensure that all the available information and technical documents for the mandated medical devices, AIMD's and IVD's corresponds to the available information in RIM and conform to necessary quality and regulatory standards and policy.
