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发帖数: 385 | 1 Quality and Regulatory Affairs Manager/ Supervisor in PCCI China Development Center, Philips Shanghai
Summary:
Under general supervision, support business staff and act as a primary liaison to business regarding product/process regulatory requirements and compliance issues. Notify quality management concerning quality and/or regulatory issues. Provide weekly status reports on assigned projects.
Initiate quality/regulatory plans for new product development. Review quality/regulatory plans for existing products as appropriate.
Duties and Responsibilities:
• Participate and review design control activity.
• Review product and process control activity.
• Be responsible for SFDA approvals, RoW coordinate with GSSI to ensure particular national requirements are met. Responsibility will be expanded to U.S. FDA510K, LTF submissions, Canadian Licensure; EU requirements for CE approbation, A/P coordinate testing, product samples as required for PAL, KFDA according to the business needs.
• Plans, coordinates and implements regulatory strategies for new products that require governmental approval.
• Serves as lead for coordinating regulatory approvals in Emerging Markets (China, Brazil, India), including mentoring other regulatory affairs professionals as required.
• Prepares marketing applications required by governmental agencies (domestic, and international) to obtain approval for regulated products.
• Maintains current knowledge of applicable national and international regulations, acts as a consultant to other departments.
• Coordinates all related government interactions and compliance activities within the organization.
• Labeling of product: Ensure content and language conforms to particular national regulatory requirements.
• Coordinate on site audit activities with national regulatory agencies and Notified Body.
• Prepares Certificate of Foreign Government as required.
• Review Marketing collaterals prior to distribution.
• Perform other duties as assigned by QA RA Manager.
Your Profile:
Knowledge/Skills/Abilities:
• Ability to manage projects involving regulatory communication and/or compliance.
• Ability to work cross functionally with various departments and disciplines.
• Ability to communicate effectively in English and Mandarin both verbally and in written form.
• Excellent problem-solving skills and ability to execute.
• Ability to efficiently prioritize multiple assignments.
Experience/Education:
• BS in engineering discipline or equivalent education, experience, training.
• 5yrs experience in medical device, 10+ yrs in quality.
• Proven track record in a Quality and Regulatory Affairs position.
• Certificate of ISO 13485 internal auditor is a must
• Expert knowledge of 21 CFR, MDD, JPAL, KFDA, SFDA requirements
• Experience in manufacturing and regulatory requirements of Emerging Markets
• Experience of NPI(New product introduction) is preferred
• Knowledge of EN 60601 series standards.
• RAB certification a plus.
Interested candidates please send your resume to Emily Qian at E********[email protected], and specify where you see this position advertised. |
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