Strategic Regulatory Professional

1 week ago


Sydney, New South Wales, Australia beBeeRegulator Full time $140,000 - $175,000

Regulatory leaders who shape the future of healthcare technology

About Us

We pioneer innovative health technologies that transform millions of lives daily.

We are a global organization with deep technical knowledge, strong regulatory partnerships and integrity at the heart of our innovation.

Career Overview

This role is part of a team responsible for Regulatory Affairs leadership for product development projects where Sydney is the legal manufacturer.

The team collaborates with global stakeholders to define and execute regulatory strategies, deliver submission-ready documentation, and enable cross-regional compliance.

Job Responsibilities

  • Lead RA strategy and delivery for NPI projects owned by Sydney.

  • Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs.

  • Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations (e.g., 510(k), CE Mark, TGA, MDSAP).

Key Requirements

  • Bachelor's degree in biomedical engineering, life sciences, regulatory affairs, or 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).

Preferred Qualifications

  • Prior experience leading RA strategy for a legal manufacturer or global product line.

  • Experience working on design and development teams under design control processes.

How You Fit In

You are a strategic operator and a team builder—a person who thrives on connecting the dots between business goals, product innovation, and regulatory pathways.

You have deep RA knowledge and a practical sense for how to lead and deliver in cross-functional environments.

You bring confidence and clarity to complex regulatory decisions, and you create space for others to grow while maintaining a high bar for execution and integrity.

You're excited to shape the next chapter of regulatory leadership.



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