Regulatory & Clinical Affairs Manager

Sylke is a fast-growing medical device company pioneering silk-based wound closure technology. Our flagship sterile dressing is FDA 510(k) exempt and rapidly expanding into international markets. With 700+ customers in our first year, Sylke is now building a pipeline of new products and investing in clinical evidence with world-class institutions.

Overview

What you’ll do

• Program management: Drive pre-submission readiness for two concurrent silk-fibroin products, maintaining synchronized timelines, risk, and deliverables.
• Pathway & planning: Confirm FDA product code/predicate/special controls and EU MDR class/Annex route; prep Q-Sub inputs and NB strategy.
• Design controls & risk: Build DHF readiness and ISO 14971 risk file mapped to 510(k) and MDR Annex II/III.
• Bench & V&V: Coordinate plans/reports to FDA guidance and MDR/GSPRs.
• Packaging/transport: Partner with Engineering on dr...