Regulatory Affairs Professional

4 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $125,000 - $165,000
Regulatory Affairs Specialist

A key member of our team, the Regulatory Affairs Specialist is accountable for providing regulatory affairs knowledge and support to ensure our business meets its objectives.

Delivering product pre-market approval within the timeframe, post-market vigilance and maintenance of all related regulatory activities requires dedication and expertise. Our Regulatory Affairs Specialist will obtain necessary regulatory approvals and adhere to established internal & external guidelines and procedures.

Key Responsibilities:

  • Provides regulatory support for products prior to launch.
  • Regulatory pre-market activities, addressing all submission requirements, comply with 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/requirements that may have potential risk to impact our business.
  • Conduct post-market vigilance, reporting including product changes, adverse event reporting, recalls and advisory notice activities.
  • Maintains regulatory documentation and electronic databases.
  • Monitors & maintains RA libraries of external regulatory standards, reference and guidance documentation.
  • Addresses internal/external customer regulatory enquiries/requests.
  • Participates in regulatory Authorities/Agency inspections as needed.
  • Main conduit to liaise with local Authorities for registration & licensing activities.
  • Collaborates and engages with global RA functions for necessary documentation, when required.
  • 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 programs.
  • When necessary, support the internal audit program.

Requirements:

  • 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 programs.
  • 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 of 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.

Benefits:

  • We offer a variety of options, including salary packaging 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.

About Us:

We are a leading company in the life science industry, dedicated to advancing the discovery process and transforming the fields of science and healthcare. We help people everywhere live longer, healthier lives.

Contact Information:

Please note that we do not accept agency resumes unless authorized by a Bio-Rad Recruiting Representative. Thank you for your understanding.

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