Ra Spec

7 days ago

Singapore Bio-Rad Laboratories Full time

Overview:
The successful incumbent will:

- Handle IVDR changes to ensure changes are approved on time in Southeast Asia
- Handle regulatory activities such as new registration, change notification and renewal according to local regulations
- Support global FSC/ISO13485/HSA manufacturer license requests

**How You’ll Make an Impact**:

- Handle IVDR change assessment and ensure on track change filing.
- Support Channel partners for new / renewal requests in SouthEast Asia
- Align product registration submissions according to commercial plan and regular reporting of status and/or challenges
- The duties include administrative duties in Trackwise digital database, respond to incoming requests for Channel Partner's registrations and provide country registration documentation according to schedule.
- Work with Channel Partner to provide documentation that is required for each country registration and communicate it back to Division for license submission. Update project team on status of registration for medical devices
- Support global FSC/ISO13485/HSA manufacturer license requests

**What You Bring**:

- Degree in pharmacy or life sciences
- Minimum 3-4 years of relevant RA working experience in IVD medical devices industry
- Proficient in Trackwise digital Salesforce
- Ability to work with individuals at all levels, both internal and external to the organization
- Ability to prioritize tasks and exercise good judgment
- Work independently
- Detail oriented

**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 well-being 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.

**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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