For our customer, one of the largest pharmaceutical companies in the world, we are looking for 
Medical Device Expert in Risk Management (m/w)
Schaftenau
19.04.2019
8462
Main Tasks:
• Ensure timely completion and quality of the assigned risk management files.
• Lead specific risk management activities within projects, as agreed with project leaders
• 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.

An ideal candidate would have at least 5 years of experience in medical device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices for parenteral administration. English level C1.

The ideal candidate would have experience generating DHF (Design History File) documentation
.

 
Requirement for the role are:
• Excellent technical writing skills (e.g., Design Controls)
• 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 of primary containers development (e.g. prefilled syringe)
• Good technical knowledge of autoinjector development
• Good communication skills
• General understanding of Human Factors Engineering and Risk management
• General understanding of clinical trial processes and requirements
• General understanding of pharmaceutical development

 
The gross salary depends on experience and training, but is at least EUR 3.163,33.- (full-time basis). The willingness to overpayment with appropriate qualification is given.

working hours: Monday- Friday, fulltime (38h per week)
start: as soon as possible
place of work: Schaftenau
Christiane Feiersinger
Kundl Sterzingerstraße 1 Innsbruck 6020 +43 5338 200 2963+43 664 815 47 32 office.kundl@adecco.at