RA Specialist

A key member of the Regulatory Affairs Function in Hong Kong.

Maintain and deliver product registration within the timeframe, due to the new regulations in place for mandatory product submission to support existing business.

Establish and improve critical RA processes to streamline and implement controls for compliance.

Key liaison with local authorities and work on getting relevant local licenses critical for operations such as medical devices, antibiotics, poisons etc.

 

  How You’ll Make an Impact:

 

Provides regulatory support for products prior to launch.

Regulatory pre-market activities, addressing all submission requirements, comply with the mandatory guideline, and tracking registration timelines to ensure plans are aligned with commercial objectives.

Set up and maintain controls in SAP for sales of authorized IVD MDs

Maintain existing licenses by ensuring timely renewal and changes are filed, approved in timely manner

Conduct post-market vigilance, reporting including adverse event reporting, recalls and advisory notice activities

Address internal/external customer regulatory enquiries/requests

Support regional regulatory submissions, when necessary

Monitor & maintains department’s library or external regulatory standards, reference and guidance documentation.

Participates in regulatory Authorities/Agency’s inspections as needed

Maintains regulatory documentation and electronic database.

Main conduit to liaise with local authorities such as Drug office and Medical device department for licensing activities

Collaborate and engage with global RA function for necessary documentation, when required.

When necessary, represent RA department on regional projects. Acting as a subject matter expert through team collaboration with all stakeholders to ensure regulatory deliverables are achieved.

Support regional regulatory submission or any other regulatory projects and duties assigned by manager

Quality Assurance (QA):

Support internal audit program and liaise with local business functions to close actions

Support Quality Management system and improvement program

Support external audit at 3PL and office for certification

 

What You Bring:

 

Tertiary education (Science or equivalent)

     At least minimum 6 year of RA and/or QA in medical device, Diagnostic, Healthcare, Sales & Distribution environment.

Basic analytical, communication, problem solving, critical thinking, and computer skills.

Working knowledge of policies, practices and procedures relating to Regulatory Affairs.

Proficient in SAP

High attention to detail, and high degree to independence.

Excellent team player able to work collaboratively and cross-functionally in a fast-paced environment.

 

 

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 our people, and this is the reason why our Total Rewards deliver programs that provide value, quality, and inclusivity while satisfying the diverse needs of our evolving workforce. Our 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 comprehensive medical plans and insurance, wellness programs, extensive learning and development opportunities and more.

 

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.

 

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Legal Entity: (HKG_3015)Hong Kong Branch of Bio-Rad Pacific Limited