Medical Devices Certification Officer, Lugano

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 processExcellent 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

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