RA Manager, Medical Device

Found in: Talent CN S2 - 2 weeks ago

Beijing, China Bayer Full time

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

RA Manager, Medical Device 

YOUR TASKS AND RESPONSIBILITIES

Prepare for the registration strategy of new product and make the project plan. Lead registration process for new product based on strategy and plan. Manage regulatory activities for maintenance of marketed products Closely monitor projects progress and keep the project timeline. Prepare HA submission dossier. Feedback test lab, HA and other stakeholders timely. May be assigned other tasks such as SOP/OI Taskforce contribution, RA intelligence and competitor information etc. Review and approve Chinese labeling. Ensure the compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior Communicate the project dashboards of responsible pre market submission projects with key stakeholders and management team Facilitate the type testing activities, tracking and resolve the open issues with engineering team in timely manner and obtain the reports without post market compliance risks Conduct assessment and gap analysis for new standards and regulations Conduct regulatory assessment of design changes without compliance issue Other tasks assigned by management

WHO YOU ARE

Advanced technical degree in Electrical Engineering or Bio medical Engineering or BS with above 5 years of regulatory experience Excellent knowledge of NMPA Regulations on medical device administration Working knowledge of medical device development and product maintenance requirements Excellent written and verbal communication skills and proficiency in English Demonstrated planning and organizing, customer focus, and cross functional/teamwork skills

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