Beschreibung

In this role, you will play a crucial part in ensuring that healthcare products meet regulatory standards. Daily tasks will involve overseeing compliance processes, conducting audits, and collaborating with cross-functional teams to enhance product safety and reliability.

Anforderungen

• •University Degree in Engineering, Computer Science, or Science or equivalent
• •Minimum 3 years of experience in a regulated industry
• •Ability to work independently towards project deadlines
• •Strong attention to detail
• •Subject matter expert in regulatory affairs
• •In-depth knowledge of health care quality standards and requirements
• •Awareness of Medical Device product safety and security standards
• •Expert PC operation skills
• •Knowledge of Microsoft Office applications (Intermediate to Advanced preferred)
• •Mandatory language skills: German, English at least C1 or better

Aufgaben

• •Ensure process adherence for pre-market procedures
• •Verify completeness of design history files and regulatory submissions
• •Ensure regulatory and process conformance in development and maintenance projects
• •Create and maintain key regulatory deliverables for projects
• •Coordinate regulatory and CE submissions with regional QARA organizations
• •Moderate the medical device risk analysis process for the development team
• •Facilitate regulatory compliance in design control processes
• •Conduct internal audits and defend pre-market activities during external inspections
• •Act as a QARA ambassador on product teams

Tools & Technologien

Benefits