Auditor - Technical File Reviewer

EPM Scientific; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A certification company is seeking an Auditor for a remote position in Germany. The role involves conducting technical file reviews and audits of active medical devices, ensuring compliance with legal standards. The ideal candidate should have a relevant degree, experience in technical file reviews, and be fluent in German. Strong communication and project management skills are also needed. This position offers the opportunity to work with diverse medical technology clients.

Qualifikationen

• Familiarity with active medical device products.
• Experience in active medical device technical file reviews and testing/inspection.
• Fluent in German language (written and spoken).

Aufgaben

• Participate in reviews of technical files related to laws and regulations for active medical devices.
• Conduct conformity assessments to international/regional standards and evaluate technical documents.
• Ensure technical files comply with standards and identify any issues with product safety.

Kenntnisse

Audit

Communication skills

Project management

Fluency in German

Ausbildung

Bachelor's, Master's or Doctoral degree in Biology, Chemistry, Pharmacy, Medicine, Agriculture, Veterinary Medicine

Jobbeschreibung

Our client is an established notified body with international operations. They test, audit, inspect and advise medical technology clients.

They are looking to add an Auditor to the team in Germany conducted technical file reviews and audits of active medical devices.

The certification company have offices in Germany and internationally, however this is a remote position.

Duties

• As Auditor, you will participate in reviews of technical files related to domestic and international laws and regulations related to active medical device. This will be across med tech and diagnostics products
• You will conduct conformity assessment to international / regional standards (ISO13485 etc.) and technical document evaluations
• The aim of the position is to ensure technical files are compiled in accordance with standards and whether there are any problems with product safety, documents / files

Qualifications

• You will need familiarity with active medical device products
• Have either a Bachelor's, Master's or Doctoral degree (Biology, Chemistry, Pharmacy, Medicine, Agriculture, Veterinary Medicine, etc.)
• Experience in active medical device technical file reviews and testing / inspection
• Fluent in German language (written and spoken)
• Communication and project management skills

Desired Skills and Experience

audit, technical files, active medical devices, German, notified body