Design Quality and Regulatory Specialist
7 giorni fa
Act as the Regulatory and Quality Expert for a defined product category
- Lead the establishment of the Regulatory and Quality Plans including requirements for new product development
- Support the full 360° cycle of new product development and integrations projects for new product launches by executing regulatory and quality strategies
- Ensure proper execution of Design Control, Design Transfer, Change Management processes including rigorous construction of Technical Documentation and other QMS deliverables
- Lead the lifecycle, maintenance, and remediation activities of legacy products
- Support QA function in the resolution of non-compliance or continuous improvement projects
Biomedical Company|Great Growth Opportunity
- Master's degree in Biomedical Engineering or other Engineering degrees
- 3 to 5 years of experience in Quality or Regulatory Affairs in a medical device environment
- Demonstrated knowledge of MDD / EU MDR, ISO 13485, ISO 14971 and other international standards e.g. FDA 21 CFR Part 820
- Good working knowledge & experience in design control and manufacturing industry
- Project management skills required
- Good documentation Practices, effective technical writing skills, and demonstrated experience in records management is required
- Good communication and listening skills
- Excellent command of English (verbal and written), a second language is a plus
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, Visio) is required
- This position may require up to 20% of international travel
Our client is a biomedical company with more than 50 years of experience in the production of medical devices.
Great opportunity.
For our client, biomedical company specialized in the production of medical devices, we are currently looking for a Quality Assurance specialist
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