
Strategic Regulatory Professional
1 week ago
Regulatory leaders who shape the future of healthcare technology
About UsWe 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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