Medical device Technical Expert - Risk management / no-655

Status: 
paused
Location: 
4070 Basel (St. Johann)
Start Date: 
2018-03-01
End Date: 
2018-08-31
Hours per day: 
8,00
Hours per week: 
36,00
Workload: 
100%
Total Hours: 
960
Assignment: 

Background

For our Swiss customer located in Basel we are currently looking for (m/f) a Medical device Technical Expert - Risk management

 

Main Task 

 

  • 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.
Requirements: 

An ideal candidate would have 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 for parenteral administration. The ideal candidate would have experience generating DHF 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 
  • 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