Required skills
- Regulatory Affairs
- Quality Management
- Medical Technology
- ISO 13485
- Contract Review
- Gap Analysis
- Process Optimization
- Supply Chain Management
- Stakeholder Management
Nice to have:Pharmaceutical Industry
Languages: German
Job description
Interim mandate to review the regulatory setup of a medical device company for the South African market. Responsibilities include analyzing and optimizing regulatory processes, conducting gap analyses, and assessing risks.
Project overview
As part of an interim mandate, the regulatory setup of a medical device company for the South African market will be reviewed.
Profile of the suited interim professional:
- Analyze and optimize regulatory processes for the South African market
- Conduct a gap analysis
- Assess regulatory and contractual risks
- Review and optimize contracts with distributors and sales partners
- Conduct an audit review and assess the effectiveness of completed measures
- Advise the project team and manage stakeholder relations
- Several years of experience in Regulatory Affairs and Quality Management
- Experience in medical technology is mandatory, pharmaceutical experience is an advantage
- Solid expertise in the ISO 13485 standard
- Practical experience in dealing with international sales and supply chains
- Experience in conducting gap analyses and optimizing processes
- Experience in the regulatory review of contracts
- Fluent German and English language skills
Project details
- Start: flexible
- Location: Remote / Op afstand, Remote / From home, NL
- Languages: German
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