Anna Jensen Email & Phone Number

Responsible for updating and maintaining the Design History File (DHF) for Drug-Device Combination Products, this includes e.g. - Maintain the DMR- Maintain the Device Risk management documentation according to ISO 14791- Drive and lead changes to the Device Constituents part of Drug Device Combination Products - Update and maintain according to relevant regulation standards (21CFR, MDR, ISO 13485)Customer Complaint investigator for device related customer complaints Participate in defining strategy for LCM activities Participate and provide input to improvement initiatives, including Design ChangesCollaborate, coordinate and support CMOs.

Responsible for updating and maintaining the Design History File (DHF) for Drug-Device Combination Products, this includes e.g. - Maintain the DMR- Maintain the Device Risk management documentation according to ISO 14791- Drive and lead changes to the Device Constituents part of Drug Device Combination Products - Update and maintain according to relevant regulation standards (21CFR, MDR, ISO 13485)Customer Complaint investigator for device related customer complaints Participate in defining strategy for LCM activities Participate and provide input to improvement initiatives, including Design ChangesCollaborate, coordinate and support CMOs.

Formulation lead for a wide range of small molecule products Participate in formulation related cross organizational projects this includes e.g.: - Nitrosamine risk assessments - Allergen statements - Elemental impurities risk assessment Write, update, approve formulation and process documentation for registration purposes in connection to: - Manufacturing Projects- Questions from authorities - Renewals and applications Participate in root cause investigations Technology Transfer

Søborg, Region Hovedstaden, Danmark

Kongens Lyngby, Region Hovedstaden, Danmark