Job Description

Your Tasks & Responsibilities:


Plan and execute product risk management activities together with the project management in an agile development.

Work with cross functional teams to identify and evaluate potential safety risks and develop risk mitigation measures for hazardous situations which could occur in the use of the medical devices, health software products and components.

Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures.

Analyze various industry and regulatory sources of information for potentially applicable risks.

Participate in the development and review of the product design inputs and outputs with a focus on risk management.

Maintain the contents of the product risk management files.

Participate in internal and external audits or assessments.

Support continuous growth in excellence of our risk management community and our risk management processes.

Qualification And Experience:


B.E. / B.Tech / M. Tech


Knowledge and Experience:


12-15 years of experience in the medical device industry of which minimum 3 years of risk management experience in SaMD (Software as a Medical Device) is preferred.

You have methodological and practical experience in risk management for medical device and health software.

You have advanced knowledge about the medical device and its operation/use in customer environment. Good knowledge of relevant product standards such as DICOM, HL7, IHE and clinical workflows is desirable.

You know relevant standards and regulations of risk management, e.g., MDR, ISO 14971, IEC 62304, IEC 82304, IEC 62366, ISO 13485.

You have experience of working in geographically distributed teams.

* You have strong communication skills, are assertive and self-motivated with strong analytical and critical thinking skills.