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Noris Medical is looking for a QA/RA assistant to join our global QA/RA team!
- Regulatory support and initial registration administration of the company products in different countries.
- Administration of translations, notary, apostille, etc. of Regulatory documents.
- Update to Technical File.
Authorities:
- Routine administration of all above-indicated areas.
- Approval and control of company quality status using an internal audit system.
Experience Required:
- Proven work of at least 2 years of experience as a Quality Assurance Assistant or similar role
- Working knowledge of tools, methods, and concepts of quality assurance
- Solid knowledge of relevant regulatory standards-advantage ISO 13484
- Good communication skills, both verbal and written
- Excellent data collection and analysis skills
- Strong attention to detail
- Relevant training and/or certifications as a Quality Assurance Assistant
- Risk Associated with the job (e.g. possible effect on product safety, performance, etc.)
- Failure to execute the job as required may affect product quality or specification but does not put the user/patient at risk
- Risk type- B
Applicable QA procedures:
- All QA Procedures, and other quality-related documents – specifications, QC documents, working instructions, etc.
- See training matrix QAF 6205
- Required Training: Self-reading of all indicated documents.
- Required Qualification: Training and qualification will be provided by the Company.
Effectiveness check type
- Internal/External audit
- Review of documentation
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