Medical Devices Certification Officer

About the role

MTIC Group is seeking a Medical Devices Certification Officer to join its InterCert GmbH office in Bonn. The role focuses on delivering CE marking and ISO 13485 certification for medical devices.

Key responsibilities

• Deliver Medical Device CE Marking and manage ISO 13485 certification schemes.
• Prepare quotations, contracts, review processes and compile certification decisions under CE and ISO 13485.
• Review assessment reports and related documentation.
• Support certification office members through certification, surveillance and renewal processes.
• Delegate tasks, supervise executives and organize workflow to meet specifications and deadlines.

Required profile

• University degree or equivalent in a scientific or engineering discipline.
• Minimum 4 years experience with CE marking, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU) 2017/745 and ISO 13485.
• Excellent knowledge of certification processes and harmonised standards.
• Strong decision‑making, problem‑solving and communication skills.

Required skills

• CE marking
• ISO 13485
• Medical Device Directive (93/42/EEC)
• Medical Device Regulation (EU) 2017/745