Chinese regulatory affairs manager

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We will suggest best candidates from our tool and organise a meeting. Some of healthcare profiles are still are in China. Some are in Europe either as junior manager or still in academy.

Below is one example of profile. Feel free to tell your demand to find perfect Chinese experts.



Profile Summary:

A seasoned Regulatory Affairs Manager with over 5years of expertise in medical device regulations across China and Europe. Demonstrated ability to lead product registration, manage audits, and ensure compliance with global standards including China NMPA requirements. ISO 13485, EU MDR and FDA 21 CFR 820.

Key Skills & Competencies:

• Regulatory Expertise: Comprehensive knowledge of NMPA, EU MDR and US FDA .
• Global Market Entry: Extensive experience in cross-border product registrations, including equivalent device justification and bundling strategies for streamlined approvals.
• Technical Documentation (TD): Proficient in preparing and reviewing technical files, clinical evaluations, and performance testing protocols for both high-risk and low-risk devices.
• Quality Systems Compliance: Strong expertise in implementing and maintaining ISO 13485-compliant quality management systems and ensuring successful regulatory inspections/audits.
• Stakeholder Communication: Experienced in liaising with regulatory authorities, managing local agents, and ensuring seamless communication between international teams.

Achievements:

• Successfully registered Class II and III medical devices across China and international markets

Education & Certifications:

• Master’s Degree in Biomedical Engineering
• Diverse training of Chinese regulation of medical device and IVD

Languages:

• Native Chinese
• Fluent in English
• Proficient in German

Location and availability:

Still in China. Can start the job as in Europe as soon as possible