Clinical Quality & Evaluation Specialist (m/f/d) Clinical Research

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.

RDEA_42508
Clinical Quality & Evaluation Specialist (m/f/d)
Clinical Research
Innsbruck, Austria
Professionals Full-Time 38.5h Permanent

• Maintenance of the Clinical Research Team's quality management system, including the creation and updating of SOPs, CTQM, and relevant CIOMs in compliance with regulatory requirements and company policies
• Organization of regulatory trainings for internal and external partners
• Submission and ongoing updating of clinical study information in WHO databases and on clinicaltrials.gov
• Coordination of quality event documentation, including CAPA actions, and support during audits and inspections
• Ensuring the flow of clinical evidence from research to clinical evaluation; primary point of contact for Regulatory Affairs (RA) and Quality Assurance (QA) during audits and inspections

• Bachelor's degree or higher degree (University, FH) or its international equivalent in clinical, science, or health-related field from an accredited institution
• Good knowledge of regulatory requirements in medical technology
• Experience with MS Office, review tools, reference management, and document management is an advantage
• Excellent German and English skills, both written and spoken

• Central Location
• Employee Discounts
• Flexible Hours
• International Environment
• Onboarding
• 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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