Regulatory Affairs Specialist - New Zealand

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Bio-Rad is seeking a Regulatory Affairs Specialist in Auckland to support regulatory compliance and market access for New Zealand and potentially Australia as part of the Pacific RA team. You will act as the NZ local Responsible Person, lead regulatory submissions and license-to-deal activities, manage post-market vigilance, and liaise with authorities while collaborating cross-functionally to align with commercial goals. You will maintain regulatory documents, monitor changes, review labeling and IFUs for ANZ compliance, and support audits and QA improvements. Ideal candidates have 5+ years in regulatory affairs in medical devices or diagnostics, a science degree, permanent NZ work rights, and willingness to travel. Tip: tailor your resume to ANZ regulations, cite NZ submissions and licenses, and demonstrate strong stakeholder communication.

Overview

A member of the Pacific Regulatory Affairs team supporting regulatory compliance and market access in New Zealand and potentially also in Australia..

Providing regulatory affairs support and as the New Zealand local Responsible Person representative. Proven ability to prepare and maintain regulatory documentation, support product lifecycle activities, and collaborate cross-functionally to ensure timely market access while maintaining compliance in New Zealand.

This role will report to the Regulatory Affairs Manager based in Republic of Korea.

How You’ll Make an Impact:

·                Provides regulatory support for products prior to release in NZ in terms of product risk assessment for import and other licenses, & or permit requirements.

·                Act as regulatory liaison with local Authorities and Agencies, responding to information requests and audits.

·                Act as the primary regulatory contact and the local person responsible for license to deal.

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

·                Continual diligence and proactive 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

·                Monitor and Maintains regulatory documentation and electronic database.

·                Address internal/external customer regulatory enquiries/requests

·                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.

·                Review labelling, IFUs, and promotional materials for compliance with ANZ regulations.

·                Collaborate with Regional RA to ensure Importation condition ANZ are met.

·                When necessary, support other government requirements (OGR), to ensure product release in AU/NZ comply with local requirements, such as labelling c-tick/RMC marking, chemical (ACVM / EPA) etc.

·                Any other regulatory duties assigned by Manager.

·                When necessary, support the audit program

·               Support quality improvement program

What You Bring: 

• Familiarity with pharmacovigilance, Misused of Drugs, and or Importation conditions.
• Basic analytical, communication, problem solving, critical thinking, and computer skills.
• High attention to detail, and high degree to independence
• Excellent team player able to work collaboratively and cross-functionally in a fast-paced environment
• An undergraduate degree in Science or other relevant field
• At least minimum 5 years of Regulatory Affairs in medical device, Diagnostic, Healthcare, Sales & Distribution environment
• Ability to travel from time to time
• Valid and unrestricted rights to work in NZ permanently

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 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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