The Sr. Regulatory Analyst (based in Beijing, China) is responsible for managing all aspects of In-Vitro Diagnostic and Medical Device regulatory requirements and deliverables including supporting regulatory strategies, leading product submissions and regulatory compliance activities, supporting product certification for security and protection, and managing tactics for China Regulatory Affairs in line with corporate and divisional objectives
- Independently complete CFDA registration of In-Vitro Diagnostic and Medical Device as scheduled
- Lead clinical studies of In-Vitro Diagnostic and Medical Device to ensure that clinical studies meet requirements of GCP and technique reviewof registration
- Lead Chinese Labelling projects of In-Vitro Diagnostic and Medical Device to meet GSP requirements
- Working within the LSG RA team, provide regulatory and scientific advice to other areas of the LSG business.
- Support Security & Protection regulatory submissions, Technical Files, and label template development
- Develop contacts with distributors, consultants, and regulatory agencies.
- Review new and existing China regulations and guidance documents, and prepare impact analysis on new documents as needed.
- Participate in customer audits, as needed.
- A minimum of five (5) years of Regulatory Affairs working experience. Clinical trial experience of IVD products is preferred.
- Direct experience in communicating with Regulatory Authorities and Distributors.
- Multinational work experience, in a mid to large size company
- Should be at ease with direct communication with internal teams, management, and external regulatory agencies, distributors and customers.
- Should be organized, able to work to on multiple projects, with tight deadlines.
- High energy level; positive attitude; works well under stress; strong communicator.
- Major in life science, biological science and pharmacy from an accredited college or university. Those familiar with NGS products is preferred.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.