EPM is currently partnered with one of the leading Medical Device Manufacturers of intelligent ventilators who is seeking a Risk Manager to join their team
Responsibilities:
- Planning and implementing the risk management process throughout the entire life cycle of the devices and accessories in accordance with relevant standards.
- Monitoring compliance with risk management processes and standards, ensuring adherence to internal processes and conducting compliant risk assessments.
- Serving as the primary point of contact for inquiries related to the risk management process.
- Providing support for internal and external audits, product approvals, and communication with regulatory authorities and partners.
- Contributing to the ongoing development and training of the risk management process.
Qualifications:
- A university degree in engineering or relevant experience in a related technical field.
- Proficiency with international standards such as ISO 13485 and ISO 14971, as well as familiarity with medical device regulations like MDR 2017/745 and 21 CFR 820.
- Fluency in German and business-level proficiency in English (Level C1).
