Senior Regulatory Product Strategist

4 days ago

Sydney, New South Wales, Australia beBeeRegulator Full time $100,000 - $150,000
Regulatory Product Strategy Role

The Regulatory Product Strategy & Delivery team is responsible for regulatory affairs leadership for product development projects where the legal manufacturer resides.

Key Responsibilities:
  • Leadership and Strategy: Lead RA strategy and delivery for NPI and PLE projects, define regulatory pathways, and ensure submission planning aligns with market access timelines and business needs.
  • Cross-Functional Collaboration: Support the team and be the RA representative on product XFTs, drive alignment with key functions such as systems engineering, quality, project management, operations, clinical, and marketing.
  • Regulatory Strategy & Submission Oversight: Oversee the development and delivery of high-quality regulatory submissions globally, review and approve key submission components and assessments, ensure documentation is submission-ready and aligned with quality standards, global templates, and timelines.
  • Team Development & Leadership: Lead and coach a team of regulatory professionals, supporting career development, onboarding, and performance management, foster a high-trust culture that emphasizes accountability, regulatory excellence, and continuous learning.
  • Process Excellence & System Stewardship: Drive improvements to regulatory workflows, ensure the team uses consistent processes, applies global templates, and adheres to design control and submission SOPs.
Required Skills & Qualifications:
  • Bachelor's degree in biomedical engineering, life sciences, or a related discipline.
  • 6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
  • Proven experience supporting device submissions, excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.
  • Experience working on design and development teams under design control processes, strong organizational and time management skills, ability to lead multiple concurrent priorities.
  • Clear, structured communicator with experience influencing cross-functional partners and regulatory authorities.

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