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Taipei, TPE, 100, TW
Job details
Work flexiblity: Hybrid
Req ID: R533293
Employee type: Full Time
Job category: RAQA
Travel: 0%
Relocation: No
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Job description
About the job:
- Responsibility for ensuring on premarket submission and registration in compliance manner.
- Compilation of submission dossiers working with design divisions, monitoring and do completion for new product, line extension, amendment, update, related certification.
- Communication strategy of local submission and registration with design divisions and commercial.
- Review, track and manage Change Notification coming from divisions and do the required action.
What you will be doing:
The following include but not limited to:
- Prioritize, plan, and review product registrations for respective product lines.
- Prepare, coordinate and submit regulatory applications to the local health authority.
- Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
- Provide the management team with regular updates on product registration & regulatory trends.
- Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
- License data management on internal system and external platform.
- Participate in the post registration activities like local labeling, UDI, registration data management, etc.
Who are we looking for:
- Degree holder, healthcare/medical/engineering related major is preferred but not limited to.
- Relevant regulatory experiences in international company for 3 years.
- Ability to interact, influence and partner with leaders.
- Detailed oriented.
- Excellent communication skills with proficiency in spoken and written English and Chinese.
- High ethical standards and integrity.
- Well-organized and logical thinking.
- Project management, writing, coordination, and execution of regulatory items.
- Perform technical and scientific regulatory activities.
- Good at planning and business processes, patient and a great sense of responsibility.
- Project management, writing, coordination, and execution of regulatory items.
- Seeks out diverse ideas, opinion, and insights and applies them in the workplace.
- Connects and relates well with people who think and act differently than oneself.
- Chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, tradeoffs, timing, and available resources.
- Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.