Adresse
GehaltAuditor / Product Expert Medical for Active Medical Devices (f/m/d)
My client is a governing body looking for medical device auditors and/or medical device experts looking to move into auditing. Extensive training provided via the academy.
Activities & Responsibilities
- You are responsible for auditing medical device manufacturers on the basis of EC Directive 93/42/EEC and Regulation (EU) 2017/745 and the standards EN ISO 13485 and EN ISO 9001.
- You check the product documentation (technical documentation) in the field of active medical devices on the basis of the relevant regulations, e.g. EN 60601 ff. and relevant EC directives/regulations, including standard-compliant documentation.
- You write reports and documentation for certification.
- You are the contact persons for our customers in the medical technology sector.
- Comprehensive induction and appropriate further training is a matter of course.
- You are supported in becoming an auditor / lead auditor and promote your professional development and further development in your product expertise.
Experience & further qualifications
- A successfully completed degree in natural sciences or engineering (e.g. medical technology, electrical engineering)
- Proof of at least 4 years of professional experience. Of which at least 2 years in the development, production, quality assurance, quality management or regulatory affairs of active medical devices, e.g. for ventilators, imaging or therapeutic procedures with ionizing or non-ionizing radiation or active surgical instruments
- Dealing with the EC directives/EC regulation for medical devices as well as the applicable standards for QM systems and medical devices is part of your daily work
- Basic knowledge in the field of approval of medical devices
- Fluent in German and English (from B2.2) in spoken and written
- Class B driving licence for working in the office and in the field
Job Type: Permanent
Salary: 65,000.00€ - 78,000.00€ per year
Work Location: Remote
