Medical Devices Certification Lead – CE/ISO Expert

MTIC Academy; Ticino; On-site; CHF 51,000 - 69,000; Full time

Job summary

MTIC Group, a multinational Notified Body and Accredited Certification Body, seeks a Medical Devices Certification Officer for its InterCert GmbH office in Bonn, Germany. The role covers CE marking, ISO 13485 scheme management, review of certification documents, and support through certification, surveillance and renewal processes.

Leadership and organizational skills are essential for driving performance. Candidates must hold a scientific/engineering degree, with at least four years in CE

Qualifications

• University degree (or equivalent qualification) in a relevant scientific or engineering discipline.
• Extensive knowledge of CE marking and Medical Device Directive/Regulation and ISO 13485 for Notified Bodies.
• Excellent knowledge of the main horizontal harmonized standards.
• Very good knowledge of English.

Responsibilities

• Delivering Medical Device CE Marking and ISO 13485 scheme management.
• Review assessment reports and other relevant documents.
• Support the Medical Device Certification office members through the certification, surveillance and renewal processes.
• Qualification of the experts and auditors.
• Delegate responsibilities and supervise the work of executives providing guidance and motivation to drive maximum performance.
• Organize workflow to meet specifications and deadlines.
• Monitor process to resolve issues.

Skills

Decision making

Problem solving

Communication

Leadership

Attention to detail

Education

University degree

Job description

MTIC Group, a multinational Notified Body and Accredited Certification Body, seeks a Medical Devices Certification Officer for its InterCert GmbH office in Bonn, Germany. The role covers CE marking, ISO 13485 scheme management, review of certification documents, and support through certification, surveillance and renewal processes.

Leadership and organizational skills are essential for driving performance. Candidates must hold a scientific/engineering degree, with at least four years in CE