Design Assurance Manager (m/w/d), corpuls Kaufering (Hauswiesenstraße)
Core
Responsible for Design Assurance of medical devices and software solutions, ensuring release compliance with quality and regulatory requirements, with a focus on US market and FDA topics.
Role type
Design Assurance Manager
Builds
Innovative high-end medical devices for emergency and intensive care
Domain
Medical Devices / Regulatory Compliance
Required skills
Regulatory knowledge for medical devices (Europe, FDA), Software as a Medical Device requirements, Technical understanding, Analytical work style, MS Office
Preferred skills
None stated
Technologies
None stated
Responsibilities
Ensure release of products and software solutions under quality and compliance requirements; Support regulatory questions, especially for the US market and FDA; Review development projects and deliverables for process compliance; Evaluate test strategies, test plans, and test results; Analyze quality data and identify optimization potentials; Plan, conduct, and accompany audits; Ensure compliance with legal, regulatory, and normative requirements; Coordinate with internal and external partners and authorities; Create and review quality and supplier agreements.
Seniority
Manager