Auditor for Active Medical Devices (m/f) (HomeOffice based) Job in Isenburg, Germany

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Auditor for Active Medical Devices (m/f) (HomeOffice based) Job Description

We are currently looking for an experienced expert from the medical devices branch as
 
AUDITOR FOR ACTIVE MEDICAL DEVICES (m/f)
AUDITOR FÜR MEDIZINPRODUKTE (m/w)
for the DACH region (HomeOffice based)
 
 
Medical Devices are some of the most regulated products in the world. In this role, you will be a part of the UL Medical Regulatory Team. Working with limited supervision, you will independently assist and support processing of manufacturer submissions to the Medical Device Directive 93/42/EEC, ISO13485 and MDSAP. This is a great opportunity to apply your industry experience.
 
YOUR RESPONSIBILITIES
Within the framework of our highly regulated Notified Body you will:

• Perform quality management system audits against European Directives with particular focus on the DACH and German speaking customers 
• Support regular unannounced audits
• Subject to training and qualification milestones
• Support Competent Authority (MHRA) activities on as needed basis e.g. MHRA witnessed audits of UL
• Provide support to customers inquiries, meetings and other customer events 
• Participate in regular training on ISO standards, applicable regulations and associated guidance
• Frequent European and international travel is required

Auditor for Active Medical Devices (m/f) (HomeOffice based) Job Requirements

YOUR PROFILE
 

• Degree or equivalent in Science discipline e.g. Physics, Electronics, Engineering
• At least 4 years industry experience with active medical devices in one or more of the following roles – R&D, Manufacturing or Quality Assurance/Regulatory Affairs
• Familiar working with quality management systems certified to ISO 13485 
• Auditing experience, ideally with another registration body or taken an IRCA registered course or conducting internal audits
• Fluent in German with good command of written and spoken English

Auditor for Active Medical Devices (m/f) (HomeOffice based) Application Information

Please apply with your CV and cover letter by the 'apply' button below

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OUR OFFER
 
We are offering a profound familiarization, the integration to a professional team, a chance to take over accountability in a relevant role and the career opportunities of a global company. Our employees benefit by being part of UL of an attractive, continuous training program to develop their personal and professional skills. Via an incentive plan, they are directly participating in the company’s success.

Auditor for Active Medical Devices (m/f) (HomeOffice based) Summary

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