Senior RA Manager

Leads a team to set up regulatory strategy and efficiently implements the strategies


Your new role

1. Leads a team to set up short-term and long-term regulatory strategy and efficiently implements the strategies to ensure successful market access of new products, transitioning/maintaining/updating the existing licenses/approvals, and regulatory compliance; 2. Establishes and implements local procedures to ensure regulatory submissions, approvals are the most efficient per regulation requirements and international guidance where applicable; 3. Develop, initiate, and revise procedures to regulatory affairs to ensure compliance to the medical device and disinfectant products and company policy; 4. Ensure the medical device GSP filing being efficient and successful and regulatory compliance (promotions material, graphics, complaints, AEs, field actions, health authority audit, etc.); 5. Support the team to collect, monitor, analyze and interpret product relevant regulations, industrial standards, national standards professionally; 6. Provides strong support to and communication with internal stakeholders to support business growth; 7. Provide strong support to audit, post market surveillance activities from regulatory perspective; 8. Monitor new and revised regulatory requirements, proactively influences local authorities (inclusive of but not limited to NMPA and NHC) on relevant regulations, guidance, and standards, timely analyze and communicate new/changes of the requirements;

What you'll need to succeed
1. Bachelor degree in bioscience or a comparable combination of education and experiences; 2. >8 years regulatory experiences in MNC medical device company; 3. Demonstrates profound knowledge and expertise in medical device regulations in China; 4. Expertly manages regulatory activities across product lifecycle; 5. Proactively and accurately assesses and interprets regulatory requirements and impacts and timely feedback to relative counterparts; 6. Obtains faster approval with effective assessments and robust proposals; 7. Experiences in complex regulatory activities, effectively and efficiently facilitates the discussions with regulatory authorities; 8. Promotes regulatory function by sharing regulatory expertise; 9. Collect the regulatory intelligence and feedback to all counterparts timely; 10. Stakeholder management; 11. Incorporate local requirements, business needs objectives and priorities in development of local regulatory strategies and *** positions; 12. Experience with/participation in Regulatory Authority Inspection/Audit 13. Good communication skill, fluent in English 14. Strong Leadership

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1232072

Summary

Job Type
Permanent
Industry
Healthcare & Medical
Location
Beijing
Specialism
Life Sciences
Ref:
1232072

Talk to a consultant

Talk to Sarah Ma, the specialist consultant managing this position, located in Beijing
501, Tower 1, China Central Plaza, 81 Jianguo Road, Chaoyang District

Telephone: 18935001739

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