Risk Management Professional
Key Responsibilities:
* Analyze and assess risks related to product development, manufacturing, post-market surveillance, usability, biocompatibility, cybersecurity, vigilance, compliance, etc.
* Develop strategies to minimize risks and improve processes.
* Ensure compliance with ISO 14971, ISO 13485, MDR 2017/745, 21 CFR 820, IEC 62304, IEC 62366-1, ISO 60601-1, ISO 10993-1/18562, IEC 81001-5-1 or other industry regulations.
Required Skills and Qualifications:
* Bachelor's or Master's degree in Engineering, Biomedical Engineering, Quality Management, Regulatory Affairs, or a related field.
* Minimum 2-5 years of experience in risk management, compliance, or quality assurance.
* Understanding of risk assessment tools (e.g., FMEA, HAZOP, PHA, FTA) and regulatory requirements.
* Strong analytical, communication, and problem-solving abilities.
* Fluent German (at least C1) and English (at least B2) language skills or willingness to learn independently.
Benefits:
* A motivating working environment.
* Variety of leisure activities.
* Modern working conditions.
* Pleasant working environment with open communication at eye level.
Salary and Job Description:
The Risk Manager is responsible for the development, implementation, and monitoring of the organization's risk management activities. This includes identifying, assessing, mitigating, and monitoring risks in various areas such as product development and product life cycle.