Coordinate and keep oversight over medical device or IVD medical device (study) co-submissions with BioNTech’s medicinal product candidates
Ensure ongoing compliance with relevant global regulations and requirements (e.g., Contribute to regulatory intelligence by monitoring, analyzing, and communicating changes in the emerging global regulatory landscape to ensure compliance and proactive strategic planning
Manage regulatory assessments of product changes (during development and post-market) and changes in the global regulatory landscape potentially affecting BioNTech’s drug developments and/or approvals
Master's degree or PhD) or extensive professional experience (typically 5 years) in a related field
DIN EN ISO13485, GCP for laboratories). Experience in support of internal and external audits and inspections by regulatory authorities (e.g., study submission packages for US FDA, EU IVDR) for medical devices or IVD medical devices, while integrating regulatory/health authority guidance and international standards into internal company documents
Knowledge of global regulatory/health authority guidelines (e.g., FDA, MDCG) and international standards (e.g., Proficient in MS Office, with desired expertise in design control, validation studies, risk management, and audit/inspection support (e.g., Communication Skills: Experience in effectively communicating with international Health Authorities and fluency in English (written and spoken)
Your Benefits:
Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
Job ticket | Deutschlandticket
Apply to our Mainz, Germany location by sending us your documents via our online form.