Auditor - Technical File Reviewer

EPM Scientific; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

An established notified body is looking for an Auditor for a remote position in Germany. The role involves conducting technical file reviews and audits of active medical devices, ensuring compliance with international standards. Candidates should have a relevant degree and familiarity with medical device regulations, alongside strong communication and project management skills. Fluency in German is essential for this position.

Qualifikationen

• Familiarity with technical file reviews for active medical devices.
• Degree in relevant scientific discipline (Biology, Chemistry, Pharmacy, Medicine, etc.).
• Experience in testing and inspection of active medical devices.

Aufgaben

• Participate in reviews of technical files for compliance with laws and regulations.
• Conduct conformity assessments to international standards (e.g., ISO13485).
• Ensure technical files are compiled according to standards, identifying safety issues.

Kenntnisse

Familiarity with active medical device products

Communication skills

Project management skills

Ausbildung

Bachelor's, Master's, or Doctoral degree

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