5+ years experience in regulated mp/ivd environment
Iso 13485, iso 14001, iso 27001 implementation
Internal auditor qualification required
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Roche is seeking a Manager for Quality and Regulatory Compliance in Mannheim, Germany, to oversee the adherence to quality standards and regulatory compliance within their diagnostics division. The role emphasizes strategic partnership, project management, and a commitment to continuous improvement in healthcare delivery.
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Job Summary
This role serves as a strategic partner to the German sales organization, ensuring innovation meets the highest quality and compliance standards.
The position involves maintaining and developing Quality Management Systems according to ISO 13485, ISO 14001, and ISO 27001 while leading Business Continuity initiatives.
Roche offers a culture of personal expression and genuine connections where employees are valued for their unique qualities in a dynamic international team.
Matching Summary
Match Score: 75
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Roche is seeking a Manager for Quality and Regulatory Compliance in Mannheim, Germany, to oversee the adherence to quality standards and regulatory compliance within their diagnostics division. The role emphasizes strategic partnership, project management, and a commitment to continuous improvement in healthcare delivery.
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Skills & Requirements
Must-have
5+ years experience in regulated MP/IVD environment
ISO 13485, ISO 14001, ISO 27001 implementation
Internal auditor qualification required
Business Continuity Management framework expertise
Medical device regulatory compliance knowledge
Nice-to-have
Agile project management methodology experience
Strong intercultural communication skills
Growth mindset with customer orientation
Strategic partnership capabilities
Risk analysis and non-conformity management
Key Requirements
Bachelor's degree in natural or engineering sciences
Minimum 5 years professional experience in regulated medical device sector
Proven track record in audit planning and execution