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Senior RA/QA Manager

Keywords / Skills : Senior RA/QA Manager

10 - 10 years
Posted: 2019-02-09

Nationality
Singapore
Industry
Recruitment/Staffing/RPO
Function
IT
Role
Legal Advisor
Posted On
9th Feb 2019
Job Ref code
9280
Job Description
Rare opportunity to join a global medical solutions provider Exposure to wide array of products portfolio and ASEAN countries Amazing company culture with great benefits and learning opportunities A global renowned medical devices provider is inviting highly motivated, independent and meticulous senior regulatory affairs manager to join their vibrant team. You will be responsible to assist with successful business operations with appropriate regulatory strategies in place and provision of guidance to strengthen the current RA team. Responsibilities Engage in regulatory intelligence: design and implement appropriate regulatory strategies in accordance to various regulatory bodies across APAC regions to achieve successful approvals Maintains global regulatory knowledge and provide strategic and functional guidance to region for quality issues and regulatory Assumes core contact role, liaising and engaging in effective negotiations to both internal and external stakeholders. Establish and maintain current QMS. Able to identify gaps and provide appropriate solutions to improve the system. Ensure internal audit program are in place and conduct internal audits wherever necessary for all APAC regions. Leads the RA team in submissions for new products, renewals and changes, as well as post-market compliance activities (e.g. adverse event reporting, recalls, complaints, etc) Requirements Minimum 10 years in the field of quality and regulatory affairs management in a medical and/or safety device company with 5 years of management experience In depth knowledge in QMS in ISO 13485, EU Medical Device Directive, US FDA 21 CFR part 820 standards and NMPA (newly updated China’s standards) Strong interpersonal and influencing capabilities with experience working with cross-functional teams Ability to adapt to fast changing environments and culture Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).
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