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:
1. Planning and implementing the risk management process throughout the entire life cycle of the devices and accessories in accordance with relevant standards.
2. Monitoring compliance with risk management processes and standards, ensuring adherence to internal processes and conducting compliant risk assessments.
3. Serving as the primary point of contact for inquiries related to the risk management process.
4. Providing support for internal and external audits, product approvals, and communication with regulatory authorities and partners.
5. Contributing to the ongoing development and training of the risk management process.
Qualifications:
6. A university degree in engineering or relevant experience in a related technical field.
7. 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.
8. Fluency in German and business-level proficiency in English (Level C1).