Manager of software engineering állás, munka

POSITION DESCRIPTION We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software. - Partner with development teams...

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation