Beschreibung
We are recruiting for a Risk Engineer for a Medical Device company based in Basel. The devices being developed here are Drug-Delivery devices therefore knowledge on combination device regulations is necessary.Responsibilities:
- Lead medical device risk management activities.
- 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, for eg. 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.
Requirements:
- 5 years of 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
- 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
Contact: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.