Product Regulatory Strategist

3 hours ago

Sydney, New South Wales, Australia beBeeStrategy Full time $150,000 - $200,000
Regulatory Product Strategy & Delivery Specialist

Develop and implement effective regulatory strategies to ensure timely access to global markets for innovative healthcare products. Collaborate with cross-functional teams to deliver submission-ready documentation and drive compliance across regions.

Lead a team of regulatory professionals, guiding the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations.

  • Develop and execute regulatory strategies for new product introduction and product lifecycle engineering projects.
  • Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs.
  • Guide the development of regulatory documentation, including design input requirements, verification strategies, and risk documentation.

Requirements:

  • Bachelor's degree in biomedical engineering, life sciences, or a related field.
  • 6+ years of experience in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
  • Proven track record supporting device submissions and delivering regulatory strategies.
  • Excellent knowledge of ISO standards, including ISO 13485 and ISO 14971.
  • Strong organizational and time management skills.

Key Skills:

  • Regulatory affairs strategy and execution
  • Leadership and team management
  • Documentation development and review
  • ISO standard compliance

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