Regulatory Affairs Expert

Job description

The Position

職位概述 Job Summary :

Ensure locally launched MD/IVD products under the name of RDTW are complied with relevant regulations, including but not limited to product registrations and review of promotional materials. 確保以RDTW名義在本地上市的MD/IVD產品符合相關規定，包括但不限於產品註冊和宣傳材料審查。

Engage and maintain the good and close relationship with TFDA and other internal & external key stakeholders.與 TFDA 和其他內部和外部主要利益相關者保持良好和密切的關係。

Monitor and analyze key regulatory policy trends and translate into predictive insights to support management of product launch and during product lifecycle. Assist line manager to handle tasks and projects as necessary. 監控和分析關鍵的法規政策趨勢，並將其轉化為預測見解以支持產品上市和產品生命週期的管理。

主要工作職責  Main  Tasks & Responsibilities :

Act as the regulatory point of contact for global/regional product launch projects in planning and managing local submission projects with the alignment on local launch plan.

作為全球/區域產品上市項目的法規聯絡窗口，規劃和管理本地查驗登記專案以與本地上市計劃保持一致。

Make concrete registration plan for new and conversion products and provide strategic advices to management;

為新產品和轉換產品製定具體的查驗登記計劃，並為管理層提供戰略建議。

Ensure that company's products comply with Taiwan FDA issued regulations and registration requirements, including but not limited to: 

• New product approvals: planning, submission and liaising with regulatory authorities for marketing authorization;
• Product changes, license variations and renewals: monitoring and planning of required submissions, ensure timely approvals as required by local regulations and timeline of company implementations;
• Specifying labelling and packaging requirements;
• Perform promotional materials review, review and/or approve materials which descriptions and statements of a specific product are aligned with locally approved claims.

確保公司產品符合台灣FDA的相關法規要求，包含但不限於：

• 新產品核准：計畫及送審，與政府法規單位溝通協調以取得產品上市許可。
• 產品及許可證變更和展延：監控和規劃必要的送審和時程，確保及時核准以符合本地法規和公司實施時間表之要求。
• 確認產品標示及包裝等法規要求。
• 執行產品行銷資料審查流程，審查和/或批准其產品的敘述和說明符合該產品在本地被核准的範圍的材料。

Others 其他事項：

• Proactively deal with daily works that might have law/regulatory concerns and properly maintain corresponding documents/records as required.積極主動處理可能涉及法律/法規問題的日常工作，並按要求妥善保存相應的文件/記錄。
• Other projects or tasks assigned by line manager. 主管指派的其他任務。
• Conduct business in full compliance to Behavior in Business and Behavior in Competition 遵循為準則，合法合理開展業務活動。

主要工作許可權  Power Reserved

Observance and adherence to regulations and other contents stated in the prevailing Standard Operating Procedures and Delegation of Authority Manual  遵守現行標準作業程序和授權委託程序中規定的法規和其他內容

基本任職資格 Basic Requirements of the Job :

教育背景 Education :

Bachelor degree or above, subject in medical laboratory/engineering, pharmaceuticals or Science related fields.

大學本科以上學歷，醫學檢驗/工程、製藥或理科相關專業。

工作經驗與專業知識/技能  Experience & Skills:

• 2-5 years of experience in Regulatory Affairs in a IVD/Medical Devices company/fields 在 IVD/醫療器材公司/領域的法規事務方面擁有 2-5 年的經驗
• Fluent English in listening, speaking and written英語流利，聽說讀寫俱佳
• Strong analytical skills and business acumen  強大的分析能力和商業頭腦
• Possess the leadership to lead cross-functional teamwork, engage, and motivate the team to bring the greatest impact. 具有領導跨領域團隊合作的能力，去激勵團隊做出最大的貢獻
• Proven project management experience, addressing challenges and priority setting  成熟的專案管理經驗，能應對挑戰和確定優先順序
• Willing to work under pressure, self-starting and self-inspiring 能承受高強度的工作壓力，積極主動並自我激勵
• Team player with strong sense of responsibility, customer-centric mindset, proactive & courageous, highly self-driven with the goal to always simplify  具有強烈責任感的團隊精神，以客戶為中心的思維方式，積極主動和勇敢，高度自我驅動，以始終簡化為目標
• Fast learner in all aspects and thrive in a fast-paced environment  各方面學習能力強，在快節奏中茁壯成長

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.