Overview
RA_12509
Innsbruck, Austria
Professionals
Full-Time 38.5 h
The Regulatory Affairs department ensures that products comply with applicable regulations and standards. Our data analytics team supports regulatory decision-making, monitors product performance, identifies trends in post-market data, and ensures evidence-based compliance across global markets.
Responsibilities
* Analyze product reliability data in accordance with regulatory requirements
* Compile product reliability data and generate data analysis reports (e.g., post market surveillance data for product submissions and PSUR, risk trending, quantification of residual risks, analysis of competent authorities databases), also in coordination with other departments
* Perform software system validations in accordance with internal requirements
* Develop and maintain software systems for the analysis and visualization of product reliability data and complaint process monitoring (e.g. PowerBi reports, SPSS scripts, VBA scripts)
Profile
* University degree in technical discipline or natural sciences and minimum of 3 years of professional experience in related fields, preferably with knowledge of quality systems and regulatory requirements
* Strong analytical skills, including experience with data analysis methods, product reliability metrics, and software validation
* Proficient in data tools such as MS Office, Power BI, SPSS, and VBA; experience with automation of analyses, eager to learn new technologies
* Detail-oriented and self-motivated, able to manage confidential data and focus on complex tasks
* Excellent communication skills in English (basic German language skills required), with a high level of accuracy and discretion
Benefits
* Family-Friendly
* Fitness Classes
* Flexible Hours
* Further Training
* International Environment
* Workplace Well-Being
Further Information
Minimum Salary: Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 46,781.00).
Earliest Entry Date: This position is to be filled immediately.
Your Contact Person: If you have any questions please contact Caroline Schenk.
About MED-EL
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.
Want to join a company that helps bring the joy of sound to people with hearing loss? Apply now!
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