Senior RA Specialist

Overview

Strickly obey NMPA regulations and internal process to get products approved

Work with DIV to get Chinese labelling ready after license approval

Timely update PRER

 

How You’ll Make an Impact:

-  Ensure products are registered according to plans; oversee product registrations and maintain appropriate records for product compliance bodies  (IVD directives, FDA requirements, Electrical Safety Regulatory, et al)

-  Ensure that necessary licenses and certifications are kept updated and renewed as applicable

-  Secure compliance of products and services distributed, including import-export & transportation (regulations related to customs tariff codes and protocols, IATA regulations for hazardous good packing, declaration, labeling and shipping, et al) and new Directives.

-  Ensure the timely delivery of new regulations or regulatory environment in China, offer necessary analysis.

-  Ensure smooth and efficient communication with division RAs and local commercial team

• #LI-SL1

What You Bring：

-  At least 3~5 year work experience with MD registration (IVD field is preferential);

-  Above 1 year work experience in international companies;

-  Oral /written English skill can deal with daily work with DIVs.

-  Good communication skill;

-  Team work spirit, work passion and positive work attitude

 

 

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 25 days annual leave, 12 days sick leave, 12% housing fund, medical insurance, accidental insurance, fixed 13th bonus and variable pay depending on different jobs.

 

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.

Legal Entity: (CHN_3002)Bio-Rad Laboratories (Shanghai) Co., Ltd