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Post-Market Quality Assurance Specialist
vor 3 Monaten
About MED-EL
MED-EL is a prominent producer of advanced medical devices aimed at addressing various forms and levels of hearing impairment. Our distinctive range of implantable hearing solutions positively impacts the lives of countless individuals across more than 140 nations globally. Headquartered in Innsbruck, Austria, MED-EL employs over 2,800 professionals worldwide.
Position Overview
Post-Market Surveillance Specialist (m/f/d)
Regulatory Affairs
Innsbruck, Austria
Full-Time, 38.5 hours per week, Permanent Position
- Conducting post-market surveillance and vigilance activities in alignment with relevant legal requirements and internal protocols.
- Managing product recalls and field actions, along with the assessment and evaluation of incidents related to MED-EL products.
- Developing and sustaining workflows, processes, and procedures associated with the quality management system.
- Tracking the performance and safety of marketed MED-EL medical devices, including quality data analysis and product reliability assessments.
- Gathering and evaluating post-market data for product submissions, clinical evaluations, and PSUR/PMSR.
- Master's Degree in a technical or medical discipline (University or FH) or equivalent qualifications.
- Preferred relevant experience in vigilance and post-market surveillance.
- Exceptional command of written and spoken English; proficiency in German is advantageous but not mandatory.
- Demonstrates a responsible, independent, analytical, and solution-focused approach.
Benefits
- Central Location
- Employee Discounts
- Flexible Working Hours
- International Work Environment
- Comprehensive Onboarding
- Focus on Workplace Well-Being
Salary Information
The salary will be determined based on professional experience; the formal minimum salary according to the Collective Bargaining Agreement is €45.
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