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_12508
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Post-Market Surveillance Specialist (m/f/d)
Regulatory Affairs
Innsbruck, Austria
Professionals Full-Time 38.5h Permanent
* Performing tasks in a timely and accurate manner, in full compliance with post-market surveillance, vigilance, and complaint-related quality system procedures and processes (incl. in electronic quality management systems and databases)
* Following defined procedures for review and closing complaint investigations as well as performing incident reporting and other vigilance activities in accordance with applicable country requirements
* Preparing and approving incident reports to the Competent Authority
* Compiling and analyzing post-market surveillance data for product submissions and annual reports, including PSUR/PMSR/PRER (inlc. updates of PMSPs as required)
* Supporting implementation of Field Actions as requested as well as initiating non-conformity reports and providing data from complaint database to CAPA team when requested
* University/ FH degree, ideally with technical or medical focus e.g. medical engineering, electrical engineering, industrial engineering, biological science
* Work experience in the field of Quality Management, previous experience in complaint handling, vigilance or post-market surveillance activities would be a plus
* Excellent communication skills in written and spoken English, German skills are a plus
* MS Office proficiency and good general computer skills
* Profound organizational skills, analytical thinking, be self- motivated and have detail orientated 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.