Medical Device Safety Specialist
vor 1 Monat
We are seeking a skilled Medical Device Safety Specialist to join our team at MED-EL. In this role, you will be responsible for performing post-market surveillance and vigilance activities in accordance with applicable statutory requirements and internal procedures.
Key Responsibilities:- Surveillance Activities: Coordinate recalls and field actions as well as establish and maintain quality system related workflows, processes, and procedures.
- Data Analysis: Monitor performance and safety of marketed MED-EL medical devices, including quality data trending and product reliability analysis.
- Incident Investigation: Investigate, evaluate, and follow up on incidents involving MED-EL products.
- Post-Market Data Compilation: Compile and analyze post-market data for product submissions, clinical evaluation, and annual reports.
To be successful in this role, you will need a degree in a technical/medical field or equivalent education, with working experience in the field of vigilance and post-market surveillance desired (minimum two years). You must also have excellent command of written and spoken English, German is desired but not required.
Personality Requirements:- Responsible: You will be accountable for ensuring that all post-market surveillance activities are conducted in accordance with regulatory requirements.
- Independent: You will work independently to investigate incidents, analyze data, and make recommendations for improvements.
- Analytical: You will use your analytical skills to identify trends and areas for improvement in our medical devices.
- Solution-Oriented: You will develop and implement solutions to address any issues identified during post-market surveillance activities.
We offer a competitive salary and benefits package, including flexible hours, international environment, and opportunities for professional growth and development.
Salary:The estimated annual salary for this position is €45,000 - €60,000, depending on your level of experience.
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