Senior RA and CA Specialist - Beijing, 2A Gongti North Road

Work Flexibility: Hybrid

Position summary:

This position will coordinate of clinical study including clinical agreement, study progress tracking and report availability. In the meanwhile, he or she will support regulatory team for product registration during documents preparation especially clinical related and standard related, as regulatory operation role. 

Essential Duties & Responsibilities: (Detailed Description)

• Prepare, coordinate and submit regulatory applications to the local health authority as RA role.

• Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. 

• Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.

• Identify the gap between China mandatory standards and international standards adopted by Stryker product design and development.

• Play a key role in China standard committees to voice opinions on behalf of Stryker and ensure a China standard implemented beneficial to Stryker products.

• Involve in the development of clinical needs priorities and strategies.

• Plans, schedules, and conducts clinical trial.

• Draft, review clinical evaluation report with aim of registration submission.

• Responsible for coordinating with all departments to obtain clinical related resources and expertise to support business objectives.

• Draft, review and monitor clinical investigation protocol, investigation brochure, CRF (clinical research file) and summary report to ensure up-to-date and accuracy.

• Build positive work relationship with Clinical investigation sites and Government authorities.

Education & Experience:

• Bachelor degree. Major in Medical or Engineering education background preferred.

• Familiar with ICH-GCP

• 3-4 years relevant regulatory and clinical affairs project experience

• Medical Device background preferred

Physical & Mental Requirements:

• Well-organized & focused

• Strategic and excellent problem solving skills

• Professional communication skills to deal with internal & external clients at the senior level

• A great sense of responsibility

• Good English writing and listening comprehension

Travel Percentage: None