Regulatory Strategist

1 day ago

Sydney, New South Wales, Australia beBeeStrategist Full time $160,000 - $200,000
Senior Regulatory Strategist Role

This role oversees regulatory execution for products manufactured under the ResMed legal entity. You'll lead a team responsible for shaping and delivering global regulatory strategies that span concept through launch and ensure successful navigation of global regulatory pathways.

The ideal candidate has deep RA knowledge and a practical sense for how to lead and deliver in cross-functional environments. They bring confidence and clarity to complex regulatory decisions, and create space for others to grow while maintaining a high bar for execution and integrity.

Key Responsibilities:
  • Developing and implementing regulatory strategies across product development projects.
  • Collaborating with cross-functional teams to drive design and development.
  • Leading and coaching a team of regulatory professionals.

Required Skills and Qualifications:
  • Bachelor's degree (or higher) in biomedical engineering, life sciences, regulatory affairs, or a related discipline.
  • 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
  • Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR, TGA ARTG).
  • Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.

Benefits:

You will be part of a diverse and inclusive culture that encourages individual expression and innovative ideas. The company focuses on creating a workplace that is challenging, supportive, and inspiring.


Others:

Before joining, you'll have the opportunity to learn new things and grow with the team. The company values continuous learning and development.

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