1. Manage Quality Assurance, Quality Systems, Quality Control, Regulatory Affairs, Supplier Quality, Calibration, Complaint Handling, and Document Control staff. 2. Train company employees on compliance with Quality System standards 21 CFR 820, ISO 13485 and ISO 14971. 3. Develop and implement Quality System management strategies which integrate with company annual and long term strategies. 4. Ensure company is regulatory inspection ready at all times (FDA, international regulatory bodies and customers) 5. Direct investigations and implement corrective actions to resolve complaints and non-compliance 6. Plan, coordinate and direct regulatory strategies for new products. 7. Participate with the Management Team in developing and implementing relevant business and strategic plans.
Yêu cầu công việc
1. BS/MS in Life Science or Engineering 2. Minimum 3 years of experience at the Senior Manager, Associate Director or Director level 3. Certain years of experience in Quality Systems/Regulatory Compliance submissions of Class I and Class II medical devices is a plus 4. Extensive knowledge of CFDA Medical Device Regulation, ISO 13485, ISO 14971, FDA QSR and CE marking 5. Proven track record of building successful teams. 6. Competence and confidence leading teams and developing a cohesive team atmosphere. 7. Proficient in Excel, Word, and MS Office/PC applications. 8. Excellent verbal and written communication skills in English Language.