Under general direction from the RA Manager, the position is responsible to perform product registration projects independently per assignment and commit timely completion to support new product introduction/existing product maintenance in China markets. It shall also cover other regulatory compliance matters post license approval and lead regulatory intelligence/advocacy activities on behalf of CooperVision by building and maintaining solid relationships with external industry associations and regulatory authorities.
- Establish solid regulatory strategy and plan for efficient and effective license approvals for critical NPI based on China commercial needs and global directions. Take accountabilities for the registration projects as assigned and commit approvals based on aligned plan.
- Independently propose clinical strategy and leverage all available resources to drive CER route and waive local clinical studies for accelerated product introduction/license approval.
- Independently identify potential regulatory approval risks based on changes in regulations/standards, country specific matters or other unique characteristics of the project and utilize the proper escalation process for effective communication.
- Efficiently monitor regulatory environment in China to proactively address upcoming requirements in new and changing regulations and ensure regulatory compliance of the organization all the time. Lead assessment efforts, establish robust mitigation plan and make it happen in time. Perform organizational education by various means so that every function impacted by the requirements should be fully understood and aligned.
- Establish active presence and voice out in the industry associations and standard technical committees in order to shape and influence regulatory policies and regulations in favor to CVI positions. Conduct advocacy activities through the support from local and global stakeholders e.g. Global RI team, SMEs.
- Lead compliance projects/initiatives for commercialized products at China local level and act as the key liaison with project team and ensure global directions are fully followed.
- Any other tasks and special projects as assigned.
Knowledge, Skills And Abilities
- Proficient regulatory affairs knowledge in China medical device environment and fundamental regulatory knowledge in other major international markets
- Be able to handle registration projects/regulatory compliance programs independently
- Be able to manage multiple tasks and global/regional level regulatory programs and perform with accuracy and a high attention to details
- Excellent communication/negotiation and interpersonal skills with internal and external stakeholders
- Ability to understand and communicate product knowledge and highly technical materials
- Proficient in reading, writing, listening and speaking in English
Work Environment
- General office environment
- Flexible hours to support the international nature of the job
- Approximately 5% of traveling might be required for authority and testing lab visits
Experience
- >8 years’ regulatory experience in medical device industry
- Hands on registration projects experience in Class III medical devices and experience in clinical strategy development to support product registration is a MUST
- Experience in global or regional program involvement/management is a PLUS
Education
- Bachelor degree in related Majors (e.g. biological/chemical/pharmaceutical/material/etc.)
- Job Identification 7420
- Job Category RAQA
- Posting Date 03/13/2025, 07:00 AM
- Job Schedule Full time
- Locations Yue Da 889 Center, Room 15F03-06A, Shanghai, 200042, CN (On-site)
- Company CooperVision
