
Product Strategy Leader
2 weeks ago
This role oversees the development of regulatory strategies for product launch projects in Sydney, ensuring compliance with global regulations. The successful candidate will lead a team of regulatory professionals and collaborate with engineering, project management, quality, and global regulatory partners.
The Regulatory Product Strategy & Delivery (RPSD) team is responsible for delivering safe and effective innovations that improve quality of life across more than 140 countries. This includes both new product introduction and product lifecycle engineering projects across masks, therapy devices, and their accessories.
Key Responsibilities:
- Develop and implement regulatory pathways for NPI projects owned by Sydney.
- Coordinate submission planning to align with market access timelines and business needs.
- Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations.
Accountability includes team performance, resource allocation, regulatory input into cross-functional design activities, and timely submissions across markets.
Requirements:
- Bachelor's degree 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).
Join a supportive environment where you can shape the next chapter of regulatory leadership.
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