R&D Risk Manager

Beschreibung

R&D Risk Manager

Industry: Pharma/Medical Device

Duration: to

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.

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

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;

Kind Regards

Sabina Keel

Senior Recruitment Consultant

Medical Devices Pharma & Biotech

Real Ein Geschäftszweig der SThree GmbH Claridenstrasse 34, Zurich 8002, Switzerland ------------------------------------------------

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E: s.keel(@)realstaffing.com

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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.