Requirements

Required education level
Compulsory education, CFC/EFZ, Bac. / Federal Vocational Bac.
Required experience
Between 3 and 5 years
Required language knowledge
English German
Required skills
Compliance English Medical Devices Switzerland MEDICAL DEVICES SWITZERLAND compliance Risk Management post market surveillance REGULATORY AFFAIRS medical devices switzerland english Medical devices quality assurance CAPA Regulatory Affairs 21 CFR 820 Switzerland Quality Assurance ENGLISH Complaints risk management complaints Quality assurance health authorities regulatory affairs MDD german Regulatory affairs Risk management ISO 14971 MDR QUALITY ASSURANCE COMPLIANCE German ISO 13485 / IEC 60601 gap analysis

Details

Location
Other countries
Term of employment
Full time
Sector
Medical technology

Description

Risk Manager - Scenic Switzerland - Innovative Medtech - English & German

Our client is a globally active medical devices manufacturer, in a leading market position, growing at a unprecedented rate, and with continued demand during Covid. A new role has just opened - a key position within the company, responsible for product risk management covering the entire lifecycle, from design and development through production and market monitoring.

As such, it is a broad role, working closely with hardware and software engineers, product managers, human factors engineers, clinical experts, vigilance experts, technical service personnel, complaint managers, and production staff to ensure the safety of the products, while supporting communications with health authorities and notified bodies as required.

Typically we'd expect this person to be degree qualified in the natural sciences, electrical engineering or medical technology, with a number of years experience in Quality Assurance &/or Risk Management within the Medical Devices sector, while ensuring compliance to relevant norms ISO 14971, IEC 60601-1, IEC 62366, & IEC 62304 (products are Software driven electromechanical in nature). Good interpersonal skills are essential as a vital part of this role lies in ensuring effective information transfer and discussions on risk analysis - This is urgent, a key role moving forward.

Spoken and written English is essential for this role, German is also an important requirement.

For more information on this vacancy, please contact the Senior Consultant Andrew Boroky by applying with your resume in WORD format, plus scanned copies of training certifications and work references if available.

KEY WORDS: Risk Management, Quality Assurance, Design Control, post market surveillance, Complaints, Switzerland, Compliance, Medical Devices, German, English, 21 CFR 820, MDR, ISO 13485, IEC 60601-1, IEC 62366, IEC 62304, ISO 14971, health authorities, notified body, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in Switzerland, Luxembourg, the Czech Republic, UK, Romania, and the USA, and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover

NonStop Consulting
Jun 15, 2022

Contact info

NonStop Consulting
Andrew Boroky
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Not available