דרושים » רפואה ופארמה » Regulatory expert in medical field for contact lens company

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Cooper Vision
Job Type: Full Time
Regulatory Specialist is responsible to ensure that the company meets all state, local, federal, international, and industrial regulations that apply to our products, preparation and submission of regulatory documents (technical files, FSCA, etc.), supporting customer regulatory requests and licenses renewal and registration.
Function as "Person Responsible for Regulatory Compliance" (PRRC) for MDR compliance.

1. Keeps abreast and complies with the regulatory requirements.
2. MDR Gap Analysis and preparation
3. 21 CFR Part 820 - QUALITY SYSTEM REGULATION compliance
4. Labeling Compliance
5. Technical files preparation and maintenance
6. PRRC
7. Internal audits
8. Suppliers audits
9. Suppliers control
10. Risk Management activities
11. Registrations/license renewal (Israel and worldwide)
12. RA/QA Contracts
13. CAPA
Requirements:
2-4 years of experience as RA/QA in medical device field.
B.Sc. in Chemical / Biochemical / Biotechnology / Materials Science. Engineering - advantage.
Internal and Lead auditor certification- advantage.
 
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