Required skills
- Regulatory Affairs
- Quality Management
- ISO 13485
- Medical Technology
- Gap Analysis
- Process Optimization
- Contract Review
- Stakeholder Management
- Supply Chain Management
Nice to have:Pharmaceuticals
Languages: German
Job description
Seeking a Regulatory Affairs & Quality Management Consultant for an exciting interim mandate with a quick start, offering remote and part-time options. The role focuses on South African market regulations and ISO 13485 quality management.
Project overview
Company Profile
Our client is a renowned company.
- Regulatory Affairs & Quality Management Consultant
- exciting interim mandate | quick start | remote and PT
Responsibilities
Requirements Profile
Compensation Package
We offer an exciting interim mandate.
- Regulatory Affairs for the South African market
- Quality management according to ISO 13485
- Analysis and optimization of regulatory processes
- Conducting a gap analysis
- Assessment of regulatory and contractual risks
- Review and optimization of contracts with distributors or sales partners
- Audit review and effectiveness assessment of completed measures
- Advising the project team and stakeholder management
- Several years of experience in Regulatory Affairs and Quality Management
- Medical technology experience mandatory, Pharma advantageous
- Sound knowledge of ISO 13485
- Experience with international sales and supply chains
- Experience with gap analyses and process optimizations
- Experience in the regulatory assessment of contracts
- Very good German and English skills
Project details
- Start: flexible
- Location: Deutschland, DE
- Languages: German
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Found on Michael Page DE