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- 12+ years of experience as business analyst in medical devices Regulatory Registrations guidelines (Medical Device Registrations -510K, EU MDR & IVDR)
- Experience in Product Quality Processes (CAPA, NCMR, SCAR, Medical Device Manufacturer Incident Reporting)
- Should have experience in PL/SQL, & ability to perform source data analysis and work in a software development life cycle with IT team and business teams
- Working experience within Med Device companies to design and implement processes for managing Product Regulatory Compliance & Medical Device Product Registration solutions (EU MDR & IVDR, 510-K), UDI solutions using PLM
- Good written and communication skills
- Should be a strong team player and good interpersonal skills
- Experience in implementing Data Governance Organization
- Excellent knowledge of various DG Operating models, roles and responsibilities for DG Roles
- Experience in various DG Tools like informatica Axon, Collibra and Alation
- Experience of working with Data Stewards and set up metadata
- Excellent in dealing with client and business users
- Candidate should be a good team player
- Excellent Communication & interpersonal Skill
- ID: #49562321
- State: New Jersey Raritan 08869 Raritan USA
- City: Raritan
- Salary: Depends on Experience
- Job type: Permanent
- Showed: 2023-03-27
- Deadline: 2023-05-22
- Category: Et cetera