Risk Management Specialist

2 days ago


Ballerup, Ballerup Kommune, Denmark LEO Pharma Full time
Job Overview

As a Risk Manager at LEO Pharma, you will play a crucial role in ensuring the safety and quality of our combination products.

Key Responsibilities
  • Develop and implement risk management strategies and processes in compliance with ISO14971 and ICHQ9.
  • Conduct risk assessments and analysis to identify potential hazards and mitigate risks associated with our drug-device combination products.
  • Collaborate with cross-functional teams to integrate usability and risk management activities throughout the product lifecycle.
  • Provide guidance and support to product development teams in implementing risk management best practice and owning the product risk file.
  • Conduct human factors engineering assessments to ensure the usability and safety of our drug-device combination products in compliance with EU and US regulatory requirements.
  • Stay up-to-date with industry regulations and standards related to risk management and human factors engineering.
  • Lead risk management training programs for employees to enhance their understanding and awareness of risk management principles.
Requirements
  • Masters degree in a relevant scientific discipline or engineering field. Advanced degree preferred.
  • Minimum of 3-5 years of experience in risk management of medical devices.
  • In-depth knowledge of ISO14971, ICHQ9, and ISO13485 standards and their application in risk management processes.
  • Strong understanding of human factors engineering principles and their integration into product development.
  • Experience in managing risk for combination products is highly desirable.
  • Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
  • Proven ability to work independently and lead risk management initiatives.


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