Purpose of the Role:
The RA Manager APAC provides leadership, direction and hands-on involvement with the Company's quality managements system in support of internal and external compliance standards, company objectives, and customer requirements. The RA Manager’s primary responsibilities include completing premarket authorizations in order to commercialize product, monitoring and ensuring compliance to international requirements, staying abreast of new and revised regulations, assure New Product Introductions comply with internal and international regulatory requirements, assure on-market products comply with internal and international regulatory requirements, support internal and external audits and inspections.
Key Responsibilities:
? Serves as a liaison between Sol-Millennium/business partners and the national Competent Authorities as needed.
? Manage and prioritize device registrations.
? Ensure regulatory compliance to applicable APAC and other regional-specific requirements and policies.
? Ensure currency and implementation of new and changing regulations.
? Manage inter-related global quality system compliance on all medical devices from concept through post-market activities; manage documentation.
? As necessary, support process of complaint handling/post market surveillance.
? Coordinate investigations, associated CAPAs, and non-conformances as needed.
? Assist with Incident and Field Safety Corrective Action (FSCA) reporting, in cooperation with SOLM and distributors/customers.
? Participate in the preparation of internal and external audit program.
? Assist in responses to quality system external and internal audits
? Collaborate with global and regional QA/RA teams.
Required Qualifications:
? A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree in medicine, pharmacy, engineering or another relevant scientific discipline.
? And at least 5 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
? Fluent English
? Highly desirable knowledge in international regulations including Southeast Asia, Australia, China, Korea and Japan.
? knowledge or certifications in US FDA Regulations, EU Medical Device Directive and Regulation, UK Regulations.
Work Experiences and Skills:
? Experience in Quality Assurance and Regulatory Affairs for medical devices.
? Good working knowledge of the Microsoft Office.
? Writing and approving standard operating procedures and work instructions.
? Experience as external auditor in the scope of medical devices.
? Experience in the manufacturing and design of sterilized products.
? Experience in the manufacturing and design of plastic injection molded products.