Auditor - Technical File Reviewer

EPM Scientific; Remote; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading certification organization is looking for an experienced Auditor to review technical files and conduct audits of active medical devices. This remote position requires a solid background in medical technology regulations, fluent German communication skills, and a degree in a relevant field. Candidates should be familiar with conformity assessments and have expertise in ensuring compliance with international standards like ISO13485.

Qualifikationen

• Familiarity with active medical device products.
• Bachelor's, Master's, or Doctoral degree in relevant fields.
• Experience in technical file reviews and testing/inspection.
• Fluent in German, both written and spoken.
• Strong communication and project management skills.

Aufgaben

• Participate in reviews of technical files for medical devices.
• Conduct conformity assessments to standards like ISO13485.
• Ensure compliance of technical files with safety standards.

Kenntnisse

Familiarity with active medical device products

Fluent in German language

Communication skills

Project management skills

Ausbildung

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

Tools

ISO13485

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