embecta is a global diabetes care company that is leveraging its 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 or follow our social channels on LinkedIn, Facebook, Instagram and X. 

Why join us?

A career at embecta means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work.  Here our employees can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.  Our Total Rewards program – which includes competitive pay, benefits, continuous learning, recognition, career growth and life balance components – is designed to support the varying needs of our diverse and global employees.

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.
  
  

Skills And Abilities（技能）

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 healthcare industry

Regular

embecta is an Equal Opportunity/Affirmative Action Employer.  We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.