Auditor / Product Expert Medical for Active Medical Devices (m/f/d)

Reference code: 17258 Company: TÜV Rheinland LGA Products GmbH

We share the enthusiasm for forward-looking solutions with over 28,000 people around the globe. At TÜV Rheinland you can contribute your knowledge independently and continue to develop in person. We are a team of highly qualified experts who face responsible challenges to enrich life with valuable achievements. And we all love what we do. If you want to bring your talents in a meaningful way, you will come to TÜV Rheinland. Let us take advantage of these diverse possibilities and make ourselves together on new goals. About us

TÜV Rheinland LGA Products GmbH is a leading provider of services in the field of auditing and certification of products. In the field of medical devices, the company supports manufacturers to meet the strict requirements of the EU Medical Device Regulation (MDR), the ISO 13485:2016 standard and other regulatory requirements. As an independent auditor, TÜV Rheinland examines the conformity of medical devices throughout the entire life cycle, from development to production to monitoring after market launch, thus ensuring safety and effectiveness for patients. At the same time, this makes it easier for manufacturers to access global markets.

The auditing of medical device manufacturers based on the EC Directive 93/42/EEC and Regulation (EU) 2017/745 and EN ISO 13485 and (EN) ISO 9001 are among your tasks. You are responsible for the examination of product documentation (technical documentation) in the field of active medical devices based on the relevant regulations, e.g. EN 60601 ff. and relevant EC directives/regulations, including the standard documentation. Your focus is on the evaluation of standalone software, AI-based applications and cybersecurity (EN IEC 81001-5-1) topics in the medical field. You write reports and documentation for certification and check clinical evaluations as part of your activity as an employeein (m/w/d) of a designated body. As a contact personin for our customers in medical technology, you are expecting a comprehensive incorporation. In addition, corresponding further developments are of course for us. We support you with the authorization to the auditorin / leading auditorin and promote your professional training and further development in your product expertise.

A successfully completed study of natural science or engineering (e.g. medical technology, electrical engineering) At least 4 years of professional experience. Of which at least 2 years in the field of development, production, quality assurance, quality management or regulatory affairs of active medical devices, in particular for imaging or therapeutic methods with ionizing or non-ionizing radiation Dealing with the EC Directives/EC Regulation for medical devices and the applicable standards for QM systems and medical devices is part of your daily work Basic knowledge of the approval of medical devices and related materials German language skills and knowledge of English (from B2.2) in word and written form, as well as a driving licence of Class B for the exercise of internal and external services are required

Training offers - from coaching and mentoring programs to the 'Women ́s Network'. Employee talks - Regular exchange at eye level. Well insured - accident insurance, occupational disability insurance, discounted insurance. Health protection measures - occupational sports groups, seminars, precautionary measures and more. Benefits - discounts for employees, e.g. in the sports studio or when buying a car. .