In-depth knowledge in the implementation and optimization of quality management systems according to ISO 13485 and EU MDR standards
Successful projects in the areas of CAPA, supplier management, and EN ISO 13485 audits
Strong combination of technical and analytical expertise
Select your region & language
Our content and services may vary by location.
)
)
Overview
- Availability
- Asap, full-time, onsite & remote
- Qualification
- Master in Management Analytics, Bachelor in Biomedical Engineering, Regulatory Affairs Manager Certificate
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Interim Management, Consulting & Auditing, Digital Transformation & Management Analytics, Project Management, Regulatory Affairs & Risk Management, Quality & Change Management, Verification and Validation, Capacity Building
Key-Facts
Extract from previous activities
Medical Device Company, Germany
Chief Strategy Officer
Leading strategic planning, business development, and client relationship management
Overseeing Quality and Change Management processes
Supporting financial planning initiatives
Medical Device Company, Germany
Director of Quality & Regulatory Affairs
Served as Quality Management Representative (ISO 13485) and Person Responsible for Regulatory Compliance (EU MDR 2017/745)
Head of the Quality and Regulatory Affairs Department, leading regulatory strategies and compliance audits
Promoted awareness of quality expectations and customer requirements within the organization
Led internal, external, and supplier audits
Medical Device Company, Germany
Senior Manager, Quality & Regulatory Affairs
Directed the QM/RA department and served as the Person Responsible for Regulatory Compliance
Managed the organizational management system and maintained compliance with EU MDR, ISO 13485, ISO 14971, IEC 62304 and IEC 60601-1
Led the internal audit team and managed audit processes