RA Mgr I
RA Mgr I
Organize RA activities and local QA work to ensure the operation of the company is in compliance with local FDA and other related authorities’ requirements
How You’ll Make an Impact:
- Product registration, including new registration, renewal, and modification registration;
- Regulation monitoring and action plan;
- Change analysis to be compliance with the requirements;
- RA operation SOP improvements;
- Post market surveillance;
- Quality management system maintenance to compliance to GDP;
- Management of Chinese Labeling, as well as product release in SAP
What You Bring:
- Bachelor degree or above, at lease 8 years regulatory working experience with 2 years experience of people management.
- IVD working experience is preferred.
- Good communication skill and positive thinking.
- Good oral and written English.
- Team work spirit.
- Well emotion control ability. Be able to work under pressure
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
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