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Post-Market Quality Assurance Specialist
vor 3 Monaten
About MED-EL
MED-EL is a prominent manufacturer of pioneering medical devices aimed at addressing various forms and levels of hearing impairment. Our distinctive range of implantable hearing solutions positively impacts the lives of thousands 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
Professionals Full-Time 38.5 h Permanent
Key Responsibilities
- Conducting post-market surveillance and vigilance activities in accordance with relevant legal requirements and internal protocols.
- Managing product recalls and field actions, alongside the assessment and evaluation of incidents related to MED-EL products.
- Developing and maintaining workflows, processes, and procedures associated with the quality management system.
- Monitoring 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.
Qualifications
- Master's Degree in a technical or medical discipline (University or FH) or equivalent qualifications.
- Preferred relevant experience in vigilance and post-market surveillance.
- Excellent command of written and spoken English; proficiency in German is advantageous but not mandatory.
- Possessing a responsible, independent, analytical, and solution-focused mindset.
Benefits
- Central Location
- Employee Discounts
- Flexible Working Hours
- International Work Environment
- Comprehensive Onboarding
- Focus on Workplace Well-Being
Salary Information
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is €45.
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