Auditor - Technical File Reviewer

EPM Scientific; Deutschland; Remote; EUR 60.000 - 80.000; Vollzeit

Zusammenfassung

A certification company in medical technology is seeking an Auditor to perform technical file reviews and audits for active medical devices. This role requires familiarity with relevant laws and standards and a relevant degree, alongside fluency in German. The position is remote, allowing flexibility while ensuring compliance with medical device regulations. Ideal candidates should have excellent communication and project management skills, along with experience in the med tech field.

Qualifikationen

• Must have experience in active medical device technical file reviews.
• Fluency in German (both written and spoken) is required.
• Strong communication and project management skills are essential.

Aufgaben

• Participate in reviews of technical files for active medical devices.
• Conduct conformity assessments and evaluate technical documents.
• Ensure compliance of technical files with international standards.

Kenntnisse

Familiarity with active medical devices

Fluent in German language

Communication skills

Project management skills

Ausbildung

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

Jobbeschreibung

Job Summary

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 to conduct technical file reviews and audits of active medical devices. The certification company has offices in Germany and internationally, and this is a remote position.

Duties

• Participate in reviews of technical files related to domestic and international laws and regulations concerning active medical devices across med tech and diagnostics products.
• Conduct conformity assessment to international/regional standards (ISO13485 etc.) and evaluate technical documents.
• Ensure technical files are compiled in accordance with standards and identify any problems with product safety, documents, or files.

Qualifications

• 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.

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Consulting

Industries

Medical Equipment Manufacturing

Location: Remote (Germany).