Regulatory Affairs (RA) Specialist

A key member of the Regulatory Affairs Function, accountable for providing regulatory affairs knowledge and support the business meeting its objectives, as well as regional RA activities.

Delivering product pre market approval within the timeframe, post-market vigilance and maintenance of all related regulatory activities obtain necessary regulatory approvals and adhere to established internal & external guideline and procedures.

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, submission and tracking registration timelines to ensure plans are aligned with commercial objectives.
• Continual diligence and proactive with post market surveillance, to ensure stakeholders are aware of regulatory changes/reform/requirement that may have potential risk to impact Bio-Rad’s business.
• Conduct post-market vigilance, reporting including product changes, adverse event reporting, recalls and advisory notice activities.
• Maintains regulatory documentation and electronic database.
• Monitor & maintain RA library of external regulatory standards, reference and guidance documentation.
• Address internal/external customer regulatory enquiries/requests
• Participates in regulatory Authorities/Agency’s inspections as needed.
• Main conduit to liaise with local Authorities for registration & 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.
• Set-up & maintain LDS controls / Licenses in SAP/GTS.
• Monitor SAP/GTS Block and release
• Support Global Veeva Rim
• When necessary, support other government requirements (OGR), to ensure product release in AU/NZ comply with local requirements, such as local importation, c-tick/RMC marking compliance.
• Any other regulatory duties been assigned by Manager.
• Support quality improvement program
• When necessary, support the internal audit program

What You Bring: 

• Tertiary education; Bachelor of Science or equivalent.
• At least minimum 5 year of Regulatory Affairs in medical Device, Diagnostic, and Healthcare environment.
• Participated in internal audit program.
• Basic analytical, communication, problem solving, critical thinking, and computer skills.
• Working knowledge of policies, practices and procedures relating to Regulatory Affairs.
• High attention to detail, and high degree to independence.
• Excellent team player able to work collaboratively and cross-functionally in a fast-paced environment
• Ability to travel domestically and overseas from time to time.

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 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 a variety of options, including salary packaging options including novated leasing, extensive learning and development opportunities, education benefits, employee assistance program for all employees and their immediate families and insurance offerings with our default superannuation fund. 

EEO Statement: Bio-Rad is an Equal Employment Opportunity employer, and we welcome candidates of all backgrounds. 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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