Strategic Regulatory Product Specialist

5 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000
Job Description

As a Senior Regulatory Affairs Specialist, you will play a pivotal role in overseeing regulatory execution for products manufactured under our entity. Your responsibilities will encompass leading a team responsible for shaping and delivering global regulatory strategies that span concept through launch, ensuring successful navigation of global regulatory pathways.

  • Strategic Leadership: Provide strategic direction to the regulatory team.
  • Regulatory Strategy & Delivery: Lead RA strategy and delivery for NPI projects owned by our entity, including PLE projects owned by us and other legal manufacturers.
  • Define Regulatory Pathways: Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs.
  • Design Input Requirements: Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations.
  • Risk Escalation: Escalate risks, resource constraints, or submission delays proactively and constructively, in line with the RA escalation model.
Cross-Functional Collaboration

Support the team as the RA representative on product XFTs originating from our entity, drive alignment with key functions such as systems engineering, quality, project management, operations, clinical, and marketing.

  • Early RA Input: Ensure early RA input and engagement during design reviews, change planning, and design control phases.
  • Oversee Submissions: Oversee the development and delivery of high-quality regulatory submissions globally, including US FDA, EU MDR, TGA, and other priority markets.
People Leadership & Team Development

Lead and coach a team of regulatory professionals, supporting career development, onboarding, and performance management, fostering a high-trust culture that emphasizes accountability, regulatory excellence, and continuous learning.

Process Excellence & System Stewardship

Drive improvements to regulatory workflows, including Jira tracking, RIMSYS submissions, and Confluence knowledge management, ensuring consistency in processes and adherence to global templates and SOPs.

Qualifications & Experience
  • Education: Bachelor’s degree (or higher) in biomedical engineering, life sciences, regulatory affairs, or a related discipline.
  • Experience: 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
  • Proven Experience: Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR, TGA ARTG).
  • Excellent Knowledge: Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.
  • Strong Organizational Skills: Strong organizational and time management skills; ability to lead multiple concurrent priorities.

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