Beschreibung
Device Engineer - Risk Management - NOVJP (m/f)
Reference: -en
Start: asap
Duration: 6 MM++
Main tasks:
- Lead specific medical device risk management activities within projects as agreed with project leaders
- Work with device development teams to incorporate risk management during all phases of the product life cycle from development of new products to maintenance of marketed products
- Facilitate preparation of risk analyses together with subject matter experts
- Author all relevant documents of the medical device risk management file, i.p. risk management plans, hazard analyses, risk analyses of use, design and manufacturing of medical devices, and risk management reports
- Provide guidance and training about the application of risk management on medical devices to all internal and external functions involved in risk management activities
- Ensure compliance with regulatory and normative guidelines (i.p. FDA CFR 820, ISO13485 and ISO 14971, MDR)
- Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions
Main qualifications
- In-depth experience in risk management as part of device development of drug delivery systems or drug/device combination products and experience in generating DHF documentation
- Excellent technical writing skills
- Strong communication skills
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
- Experience in product design and design for manufacturing
- Good technical knowledge about primary packaging materials and drug delivery devices
- General understanding of human factors engineering, clinical trial processes and requirements and pharmaceutical development
Main advantages:
- A very renowned company
- Interesting tasks in a multinational environment
- A city with a high quality of life that perfectly embraces both modern and traditional values
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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My contact person:
Svenja Weiß
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