Post-Market Surveillance Specialist
vor 1 Monat
We are seeking a highly skilled Post-Market Surveillance Specialist to join our team at MED-EL. As a key member of our regulatory affairs department, you will play a crucial role in ensuring the safety and quality of our medical devices.
Key Responsibilities:
- Perform Post-Market Surveillance: Conduct regular monitoring of our medical devices to detect any potential issues or defects, and take prompt action to address them.
- Coordinate Recalls and Field Actions: Collaborate with internal teams to coordinate recalls and field actions, ensuring compliance with regulatory requirements and internal procedures.
- Quality System Management: Develop and maintain quality system-related workflows, processes, and procedures to ensure ongoing improvement and compliance.
- Incident Investigation and Reporting: Investigate and evaluate incidents involving our products, and compile reports for submission to regulatory authorities.
- Data Analysis and Reporting: Analyze post-market data for product submissions, clinical evaluations, and annual reports, providing insights to inform business decisions.
Requirements:
- Technical/ Medical Degree: Hold a degree in a technical or medical field (University, FH) or equivalent education.
- Experience in Vigilance and Post-Market Surveillance: Possess a minimum of two years of experience in the field of vigilance and post-market surveillance.
- Language Skills: Have excellent command of written and spoken English, with German language skills desirable but not required.
- Personality and Skills: Demonstrate a responsible, independent, analytical, and solution-oriented personality with excellent communication and interpersonal skills.
Benefits:
- Central Location: Enjoy a convenient and accessible work environment.
- Employee Discounts: Benefit from exclusive discounts on MED-EL products and services.
- Flexible Working Hours: Enjoy a flexible work schedule that balances productivity and work-life balance.
- International Environment: Work in a dynamic and diverse international environment with a global team.
- Onboarding and Professional Development: Participate in comprehensive onboarding and professional development programs to enhance your skills and career growth.
- Workplace Well-Being: Enjoy a supportive and healthy work environment that promotes well-being and employee satisfaction.
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