Regulatory Compliance Specialist

18 hours ago

Sydney, New South Wales, Australia beBeeCompliance Full time $80,000 - $120,000

**Job Description:**

  • Regulatory Affairs Specialist
  • Assist in the development and implementation of regulatory strategies to ensure compliance with local and international regulations.
  • Prepare and lodge submissions, including conformity assessments, for changes to on-market products and updates to internal compliance records.
  • Evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards.
  • Advise global teams on local compliance needs and support innovation product maintenance requirements.
  • Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.
  • Offer mentorship and training to regulatory affairs colleagues while leveraging data to identify process improvements.

**Required Skills and Qualifications:**

  • Education:
  • A degree in science, biomedical studies, or a related field.
  • Experience:
  • At least 2-3 years of experience in regulatory affairs within the medical device or IVD sector.
  • Skills:
  • Exceptional verbal, written, and interpersonal communication skills.
  • Solid understanding of Australian and international regulatory frameworks.
  • Familiarity with ISO 13485 and other relevant quality standards.

**Benefits:**

  • Collaborative team culture that values open communication, diversity, and shared learning.
  • Opportunity to work autonomously and collaboratively in a dynamic environment.

**Others:**

  • This is an entry-level role suitable for candidates with foundational experience in Regulatory Affairs for Medical devices/In Vitro Diagnostics.
  • The ideal candidate will be proactive and resilient, with excellent multi-tasking abilities and a high attention to detail.
  • They will have the ability to work with a close-knit team consistently working towards providing insights that enable smarter, faster decisions to transform the way the world is managing health.

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