R&D Risk Manager
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R&D Risk Manager
Industry: Pharma/Medical Device
Duration: 01/02/2019 to 01/11/2020
Location: Basel-Land
Main responsibility:
* Lead specific risk management activities within projects, as agreed with project leaders
* Timely completion and ensure quality of the assigned risk management file for Medical Device
* Facilitate development and completion of risk assessments
* Ensure compliance with ISO 14971 in all development projects assigned
* Conduct and provide guidance on the use of risk analysis for Use, Products, Components and Processes
* Ensure compliance with regulatory and normative guidelines focusing on medical device risk management
* Guide internal and external functions on creating, reviewing and approving medical device Risk Management Files
* Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements
* Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects Author the documentation in the medical device risk management file.
* Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.
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Requirement for the role are:
* At least 5 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices
* The ideal candidate would have experience generating DHF documentation.
* Excellent technical writing skills (e.g. DHF, Design Controls, Verification)
* Good understanding of medical device regulations ISO13485, (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
* Experience in Product Design and Design for Manufacturing
* The ideal candidate has good technical knowledge of primary containers development, good technical knowledge of auto injector development
* General understanding of Human Factors Engineering and usability
* General understanding of clinical trial processes and requirements
* General understanding of pharmaceutical development
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Should you be interested in this or similar poistions within Medical Devices, please feel free to get in contact with me or send me your latest CV to; s.keel(at)realstaffing.com
Kind Regards
Sabina Keel
Senior Recruitment Consultant
Medical Devices Pharma & Biotech
Real Ein Geschäftszweig der SThree GmbH Claridenstrasse 34, Zurich 8002, Switzerland ------------------------------------------------
T: +41 (0) 44 588 2627
E: s.keel(@)realstaffing.com
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.