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 3,300 employees around the world.
RA_22606 Post‑Market Surveillance Associate (m/f/d) Regulatory Affairs Innsbruck, Austria Professionals Full‑Time 38.5h Permanent
Our Regulatory Affairs Department ensures that products comply with applicable worldwide regulations and standards. This department also includes our Post‑Market Surveillance Team, which is responsible for monitoring product performance after market release, managing complaint and vigilance activities, and ensuring timely reporting of incidents.
Aufgaben
Ensuring timely and accurate entry of complaint data into the company's database for complaint processing; compiling and analyzing post‑market surveillance data for product submissions and annual reports, including PSUR/PMSR
Adhering consistently to defined procedures for assigning, tracking and controlling investigations and handling of complaints per all applicable regulations
Supporting complaint investigation and vigilance activities by gathering and assessing relevant information on complaints' related events
Contributing to improvements in existing quality systems and updating relevant procedures, as required
Preparing incidents reports for submission to National Competent Authorities
Profil
University/ FH degree preferred, ideally with technical or medical focus; work experience in the field of quality management or post‑market surveillance activities are 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 and a responsible, detail‑orientated approach
Highly self‑motivated with a proactive approach to learning, combined with a collaborative, team‑oriented mindset
Wir bieten
Central Location
Flexible Hours
International Environment
Language Courses
Public‑Transportation Subsidy
Workplace Well‑Being
Minimum Salary Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 47,810.14.
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RA_22606 Post‑Market Surveillance Associate (m/f/d) Regulatory Affairs Innsbruck, Austria Professionals Full‑Time 38.5h Permanent
Our Regulatory Affairs Department ensures that products comply with applicable worldwide regulations and standards. This department also includes our Post‑Market Surveillance Team, which is responsible for monitoring product performance after market release, managing complaint and vigilance activities, and ensuring timely reporting of incidents.
Aufgaben
Ensuring timely and accurate entry of complaint data into the company's database for complaint processing; compiling and analyzing post‑market surveillance data for product submissions and annual reports, including PSUR/PMSR
Adhering consistently to defined procedures for assigning, tracking and controlling investigations and handling of complaints per all applicable regulations
Supporting complaint investigation and vigilance activities by gathering and assessing relevant information on complaints' related events
Contributing to improvements in existing quality systems and updating relevant procedures, as required
Preparing incidents reports for submission to National Competent Authorities
Profil
University/ FH degree preferred, ideally with technical or medical focus; work experience in the field of quality management or post‑market surveillance activities are 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 and a responsible, detail‑orientated approach
Highly self‑motivated with a proactive approach to learning, combined with a collaborative, team‑oriented mindset
Wir bieten
Central Location
Flexible Hours
International Environment
Language Courses
Public‑Transportation Subsidy
Workplace Well‑Being
Minimum Salary Salary will be determined based on professional experience; the formal minimum salary according to Collective Bargaining Agreement is € 47,810.14.
#J-18808-Ljbffr
