RA Spec I

Responsible for managing product registrations for the assigned product line, including new registrations, renewals, and registration changes. In addition, the role supports compliance with applicable Quality Management System requirements and TFDA Good Distribution Practice requirements for the Taiwan branch

 

 

How You’ll Make an Impact:

• manage product registrations in accordance with established plans and maintain RAQA
• handle and oversee the TFDA regulatory submissions, including new applications, renewals, and change submissions.
• handle the field action activities and post‑market surveillance in compliance with local regulations and global requirements.
• handle the implementation and maintenance of Quality Management System processes at the Taiwan branch.
• liaise with divisional Regulatory Affairs, Quality Assurance teams, and local functional teams.
• Communicate directly with relevant regulatory authorities as required.
• Complete assigned internal team tasks independently and in a timely manner.

 

 

 

What You Bring:

 

• Bachelor’s degree or above in medical, biological, or pharmaceutical‑related disciplines.
• Two to three years of work experience in IVD or medical device registration is preferred.

 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

 

Benefits: Bio-Rad's biggest asset is its people, and the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our robust offerings serve to enrich the overall health, wealth, and wellbeing of our employees and their families through the various stages of an employee’s work and life cycle.

 

We’re proud to offer up to 30 days annual leave   medical and accidental insurance. Fixed 13th month payment and variable pay are offered.

 

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with disabilities, and people of all races, ethnicities, genders, ages, and orientations are encouraged to apply.

 

Agency Non-Solicitation: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes. #L1-SL1

 

Legal Entity: (TWN_3016)Taiwan Branch of Bio-Rad Laboratories, Inc.