Medical Devices Certification Officer

MTIC Academy; Ticino; Vor Ort; CHF 51.000 - 69.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Decision making

Problem solving

Communication

Leadership

Attention to detail

Ausbildung

University degree

Jobbeschreibung

About The Job

MTIC Group Multinational Group which provides services as Notified body and Accredited Certification Body by its member companies is growing steadily and successfully in all areas of testing, inspection, and certification. Currently, we are looking for a Medical Devices Certification Officer for our office InterCert GmbH – Group of MTIC - , in Bonn, Germany.

Main Responsibilities

• Delivering Medical Device CE Marking and ISO 13845 scheme management
  
  
  
  • To carry out the quotation, contract, processes review and compile certification decisions under the CE and ISO 13485 certification schemes
  
  
  • To review assessment reports and other relevant documents.
  
  
  • To 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

Minimum Requirements

• University degree (or equivalent qualification) in a relevant scientific or engineering discipline


• Work experience of minimum 4 years in CE marking, Medical Device Directive (93/42/EEC), Medical Device Regulation (Regulation (EU) 2017/745), ISO 13485 for other NBs and excellent knowledge of certification process


• Excellent knowledge of the main horizontal harmonized standards


• Very good knowledge of English

Additional Requirements

• Strong decision-making skills and a results-driven approach


• Problem-solving skills


• Outstanding communication ability and interpersonal skills


• Excellent organizational and leaderships skills


• Attention to detail