Your Responsibilities:
- Ensure compliance with the risk management process according to ISO 14971 for new developments and existing therapy products.
- Coordinate, create, and maintain risk management files for new developments, the existing portfolio, and change management in therapy products.
- Analyze risks within the framework of CAPAs and complaints.
- Organize and moderate analysis sessions with interdisciplinary project teams in both German and English.
- Develop ideas to drive the strategic development of risk management in accordance with ISO 14971 within the company.
Your Qualifications:
- Degree in medical technology, electrical engineering, mechanical engineering, physics, or a comparable qualification.
- Proficiency in your field with professional experience in risk management according to ISO 14971.
- Experience in conducting risk analyses for electrical medical devices and medical apps is desirable.
- Ideally, experience in conducting security risk analyses in cybersecurity.
- Independent working style, strong analytical thinking skills, and a strong result and goal orientation.
- Team-oriented, strong communicator, enjoys moderating, and can communicate well in both German and English.
What We Offer:
- Leading and continuously growing medical technology company.
- Dynamic environment with an excellent working atmosphere characterized by flexibility and personal responsibility.
- Challenging and varied projects.
- Many opportunities for participation and personal and professional development.
- Flexible working hours.
- Subsidy for the Deutschlandticket.
- Lunch allowance and daily fresh fruit.
- Subsidy for company pension provision.
- Continuous training and qualification opportunities.
- JobRad.
- Home office possible by arrangement.
- Corporate Benefits.
- 30 days of vacation.
