The opportunity
Title: Regulatory Advisor - FDA Pharma & IVDR
What you'll do
Represent the regulatory function on designated cross-functional teams.
Conduct business interactions with customers and regulatory authorities: regarding regulatory pathways, performance claims, supporting data, and labeling in the context of submissions or registrations.
Build and execute bold, practical regulatory strategies for complex: regulatory affairs programs, with a heavy emphasis on FDA Pharma, IVDR, and In Vitro Diagnostic (IVD) systems.
Advocate for the least burdensome approaches to product clearance and: approval while strictly interpreting and adhering to regulatory requirements.
Coordinate and prepare regulatory submissions with minimal supervision,: including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical worldwide registrations.
Mentor regulatory associates and support their career advancement.
What they're looking for
- Deliver training on regulatory topics across internal teams.
- Lead cross-functional teams to address major regulatory changes, compliance: with new registration requirements, or process improvements.
- Contribute to setting individual and departmental annual goals aligned with business objectives.
- Review and ensure regulatory compliance of advertising, promotion, and labeling across a common product line.
