embecta, formerly part of BD, is one of the largest pure-play diabetes care companies in the world, leveraging its nearly 100-year legacy in insulin delivery to empower people with diabetes to live their best life through innovative solutions, partnerships and the passion of more than 2,000 employees around the globe. For more information, visit embecta.com.
Associate Manager, Regulatory Affairs & Quality Affairs, Taiwan (Taiwan RAQA Lead)
Ensure timely registration of new products, plus maintenance of existing registrations, for embecta Taiwan, and fulfill all regulatory compliance & operation activities and responsibilities as required.
This position is also responsible for managing and ensuring that the quality system compliance requirements are met per the relevant standards, corporate & region, TFDA and other relevant local regulation requirements.
Job Description
Major Accountabilities
- To account for the assigned new registration & maintenance projects of embecta Taiwan products by managing registration, listing and market approval in accordance with the Taiwan regulations;
- To develop and execute transition strategies and meet the compliance timelines;
- To ensure regulatory compliance to secure business continuity – medical device dealer license, product licenses, QSD, labeling, complaint handling, adverse event reporting, field actions and recall in accordance with local and global company regulatory requirements;
- To collaborate with cross functions and lead regulatory operation activities, such as labeling review & release, UDI, copy review, AdPromo material approval process, etc.;
- To monitor and analyze changes in regulatory environment trend, threats, and opportunities;
- To provide necessary inputs on quality system related matters and be willing to coordinate cross-functions for accomplishments;
- To comply with all legal, regulatory, and ethical business requirements in executing the assigned roles and responsibilities as defined in the local regulation and the Corporate procedure;
- The individual will also be responsible to fulfill other requirements as the responsible technical person for embecta Taiwan as stipulated in TFDA Regulations for Management of Medical Devices Technicians醫療器材技術人員管理辦法.
Ideal Background
Education
Minimum: B.A degree in Life Sciences, Biomedical Engineering, Chemistry, Pharmacology, Pharmaceutical sciences, or other relevant subject matter.
Languages
Fluency in both written and spoken Chinese and English
Experience
Minimum: 5 years of experiences in regulatory affairs; experience in the medical device industry
