MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable hearing solutions benefits thousands of individuals in more than 140 countries worldwide. With headquarters in Innsbruck, Austria, MED-EL has over 3,000 employees around the world.
RA_12510
Vigilance / Post-Market Surveillance Specialist (m/f/d)
Regulatory Affairs
Innsbruck, Austria
Professionals, Full-Time, 38.5h, Permanent
* Performing post-market surveillance and vigilance activities in accordance with internal procedures and applicable regulations
* Coordination of recalls and field actions as well as establishing and maintaining quality system related workflows, processes and procedures
* Monitoring performance and safety of marketed MED-EL medical devices, including quality data trending product reliability analysis and input into CAPA process
* Investigating, evaluating and closure on incidents involving MED-EL products
* Compile and analyze post-market data for product submissions, clinical evaluation and annual reports, including PSUR
* Degree in a technical/medical field (University, FH) or equivalent education
* Working experience in the field of vigilance and post-market surveillance is desired (minimum two years)
* Excellent command of written and spoken English and German, German is desired but not required
* Responsible mindset, independent working style, analytical skills and solution-oriented approach
* Central Location
* Employee Discounts
* Family-Friendly
* Flexible Hours
* International Environment
* Workplace Well-Being
Minimum Salary
Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00.
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