For our customer, one of the largest pharmaceutical companies in the world, we are looking for 
Medical Device Expert in Risk Management (m/w)
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