▷ [12 / 10 / 2025] 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 drawings / specs; ensure ISO 11607 validations (seal / dye / microbial, ISTA / D4169) acceptable to FDA / NB.
• Sterilization / micro : Orchestrate ISO 11135 / 11137 validations, SAL, bioburden / endotoxin to FDA / MDR expectations.
• Biocompatibility : Build ISO 10993 plan / rationales aligned to 510(k) and EU CER risk assessment.
• Aging / shelf life : Execute ASTM F1980 and real-time studies for U.S. / EU labeling.
• Usability / software (if applicable) : IEC 62366 / 62304 mapped to 510(k) / MDR.
• Labeling / claims : Align FDA labeling with EU MDR / IFU, languages, harmonized standards.
• UDI & registrations : Prepare data for GUDID (U.S.) and EUDAMED (EU); support Health Canada MDL / TGA.
• Clinical evidence : Coordinate IRB (U.S.) and EC / Competent Authority (OUS); assemble evidence for 510(k) and MDR CER / PMCF.
• Supplier / SC & DMR : Gather specs / BOM / DMR / traceability to satisfy FDA / MDR / MDSAP.
• Authority interactions : Organize FDA RTA / AI responses and Notified Body queries to closure.
• Executes / coordinates; final authorship / sign-off stays with leadership.

What you bring

Engagement & Compensation

Why SYLKE?

SYLKE isn’t just redefining surgical materials—we’re creating a new standard for sustainable, scalable solutions in healthcare. Join a mission-driven team of innovators, collaborators, and changemakers who believe in the real-world impact of their work. Here, you’ll help advance patient care, drive meaningful value for the healthcare community, and shape the future of surgery—one breakthrough at a time.

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