Work Flexibility: Hybrid
About the job:
The role is responsible for ensuring rapid and timely approvals on product registrations including all necessary preparation and documentation. The role supports regulatory affairs and Reimbursement to ensure regulatory compliance with government requirements and company policy.
What you will be doing:
- Possesses and applies broad and advanced knowledge, skills/abilities and understanding of the regulatory, legal and quality frameworks, regulatory requirements, legislation, processes and procedures.
- Responsibility and accountability for ensuring on premarket submission and registration in compliance manner for the assigned product lines.
- Compilation of submission dossiers working with design divisions, monitoring and do completion for new product, line extension, amendment, update, related certification, like renewal for registration/QSD certificate etc.
- Initiate to find solution and alternative way on obstacles for the registration, regulatory system and regulations.
- Build up and communicate work plan and strategy of submission and registration with design divisions and commercial.
- Execute annual planning process of submission and registration including renewal working with RA, Commercial, Finance, Operations, Design divisions as per global and local procedure.
- Monitor local regulation changes, analyze the impact, notify to divisions and stakeholders, and do the required action to prepare appropriately.
- Manage Change Notification process for the assigned product lines.
- Enhance the internal process of product registration and post registration activities like labeling, data management, etc.
- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Evaluates the regulatory environment and contributes to providing internal advice for the commercialization planning process to Marketing team to ensure product compliance
- Participate in and/or lead multinational or multi-functional project and/or advocacy activities to provide local regulatory insights driving better performance of organization
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
- Works with Marketing Dep. to apply for self-pay or reimbursed code in a timely manner.
- Submits the product registration & QSD cases per the annual plan aligned with Division
Who are we looking for:
- Bachelor’s degree in engineering, Science, or related or master’s degree in Regulatory Science.
- Minimum of 7 years’ experiences.
- Ability to interact, influence and partner with leaders.
- Detailed oriented.
- Excellent communication skills with proficiency in spoken and written English and Chinese.
- Hands-on ability to implement swiftly and effectively by taking ownership and accepting responsibility.
- High ethical standards and integrity.
- Well-organized and logical thinking.
- Good at planning and business processes, patient and a great sense of responsibility.
NOTE: Please attach an English version of your CV when applying for this role.
職位簡介：
該角色負責確保快速及時地批准產品登記，包括所有必要的準備和文件。該角色支援法規事務和健保，以確保符合政府要求和公司政策。
工作內容：
- 擁有並運用廣泛且先進的知識、技能/能力以及對法規、法律和品質架構、監管要求、立法、流程和程序的理解。
- 確保指定產品線產品以合規方式進行上市前提交和登記的責任和義務。
- 與原廠合作編制提交檔案，監控並完成新產品、新增規格、變更等相關查驗登記以及許可證與QSD 展延等。
- 著手尋找解決查驗登記、法規體系和法規障礙的解決方案和替代方法。
- 與原廠和商業部門建立並溝通工作計劃以及提交查驗登記策略。
- 根據全球和當地程序，執行提交和查驗登記的年度規劃流程，包括與 RA、商業、財務、營運、原廠合作。
- 監控當地法規變化，分析影響，通知相關部門，並採取必要的行動做好適當準備。
- 管理指定產品線產品的變更通知流程。
- 優化產品登記和上市後活動（如產品標籤、資料管理等）的內部流程。
- 評估法規資訊以協助制定當地、區域和全球法規策略
- 評估法規環境，有助於向行銷團隊提供商業化規劃流程的內部建議，以確保產品合規性
- 參與和/或領導跨國或多職能專案和/或倡議活動，以提供當地法規見解，推動組織取得更好的績效
- 預期整個產品生命週期中的法規障礙和新問題並開發解決方案
- 與行銷部門合作及時申請自費或健保碼。
- 根據與原廠一致的年度計畫提交產品登記和 QSD 申請
我們在尋找：
- 工程、科學或法規科學相關學士學位或碩士學位。
- 至少7 年以上經驗。
- 與領導者/主管互動、影響力和合作的能力。
- 注重細節。
- 優秀的溝通能力，精通中英文口語和書寫。
- 透過積極掌握工作負責內容和承擔責任展現快速有效的實踐力。
- 高道德標準和誠信。
- 良好的組織和邏輯思維。
- 善於規劃和業務流程，有耐心和責任感。
注意：申請此職位時請附上英文版簡歷。
Travel Percentage: None