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
- 5–8+ years med-device RA/CA with end-to-end pre-

📌 Regulatory & Clinical Affairs Manager (Lima)
🏢 SYLKE
📍 Lima