Required skills
- Regulatory Affairs
- Quality Management
- ISO 13485
- Medical Technology
- Contract Management
- Gap Analysis
- Process Optimization
- Stakeholder Management
- Supply Chain Management
Nice to have:Pharmaceuticals
Languages: German
Job description
Seeking a specialized Regulatory Affairs & Quality Management Consultant to review and optimize the regulatory and contractual setup of a medical technology company for the South African market.
Project overview
We are not looking for a classic QA/RA manager for day-to-day business, but a highly specialized Regulatory Affairs & Quality Management Consultant who will review and optimize the regulatory and contractual setup of a medical technology company for the South African market.
Project details
approx. 30% (higher initially)
Customer Details
Our client is a renowned company.
Job Description
Profile
Offer
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
- Execution of 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
- Consulting 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 in gap analyses and process optimizations
- Experience in the regulatory assessment of contracts
- Very good German and English skills
- Start: 2026-11
- Remote: onsite
- Location: Germany, Deutschland, DE
- Languages: German
Indexed by 9am's meta-search. You are a job provider? Claim or manage this listing
Found on FreelancerMap DE