Healthcare Regulatory Compliance Professional

2 days ago

Melbourne, Victoria, Australia beBeeRegulatory Full time $90,000 - $120,000
Job Description

Regulatory Affairs Specialist

  • Develop and execute a local regulatory plan in collaboration with internal stakeholders to ensure timely registration of our products and attainment of business objectives.
  • Submit technical documentation to regulatory authorities and secure registration approval within the required timeframe.
  • Maintain product registration throughout its lifecycle by applying relevant regulatory change control measures.
  • Provide Global RA with real-time information necessary to maintain key metrics, such as submission dates and approval dates for all product registrations.
  • Monitor and communicate new, upcoming, and changes to regulations with local stakeholders and Global RA.
  • Influence and shape the regulatory landscape where possible.
Required Skills and Qualifications
  • A minimum of a B.S. degree in biomedical science, life science, or a related field, with 2-3 years of health-related quality-focused and regulatory experience.
  • Knowledge of diagnostics is preferred.
  • Strong interpersonal communication skills.
  • Self-starter, highly motivated with attention to detail.
  • Excellent command of written and spoken English and Chinese.
  • Ability to work independently, taking general concepts and direction to produce compliant outcomes.
  • Prioritize multiple tasks and function effectively.
Why Work with Us?

We are driven by innovation to create a healthier future. Our team of over employees worldwide is committed to advancing scientific progress and ensuring access to healthcare for everyone – today and for generations to come. Through our efforts, we treat over 26 million people with our medicines and conduct more than 30 billion tests with our diagnostic products. We encourage each other to explore new possibilities, foster creativity, and set high goals to deliver life-changing healthcare solutions.

Together, we can shape a healthier future.

We are an equal opportunities employer.

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