- Establish regulatory strategy and plan (including clinical part) for efficient and effective approvals in line with business needs.
- Lead RA team to commit key milestones according to the regulatory strategy for all kinds of registration projects and manage the communication and escalation pathway in a consistent manner.
- Handle registration projects independently as needed including Clinical Evaluation Report (CER) delivery with support from external vendors.
- Identify potential regulatory approval risks based on changes in regulations/standards, country specific matters or other unique characteristics of the project.
- Collect regulatory intelligences including new and changing regulations and industry/competitor updates that affect the organization. Lead assessment efforts and mitigation plan as necessary.
- Establish and maintain close working relationship with authorities and tasting labs.
- Lead RA team to cover other relevant regulatory compliance activities like ad/promo review and packaging/labeling review.
- Any other tasks, special projects and process optimization as assigned.
Knowledge, Skills and Abilities:
Proficient regulatory affairs knowledge in China medical device environment and fundamental regulatory knowledge in other major international markets
Ability to understand and communicate product knowledge and highly technical materials
Excellent communication and interpersonal skills with internal and external stakeholders
Be able to manage multiple tasks and perform with accuracy and a high attention to details
Proficient in reading, writing, listening and speaking in English
Team management experience is desired
Work Environment:
General office environment
Flexible hours to support the international nature of the job
Approximately 10% of traveling might be required mainly for authority and testing lab visits
Experience:
> 6 years’ regulatory affairs experience in medical device industry
Hands on experience in Class III new product registration
Experience in clinical affairs or medical affairs is a plus
Education:
Bachelor degree or above in related Majors (e.g. biological/chemical/pharmaceutical/material/etc.)
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