Regulatory & Clinical Affairs Manager

hace 4 días

Lima Metropolitana, Perú SYLKE A tiempo completo

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-510(k) readiness; contributed to ≥2–3 510(k) programs through Q-Sub/RTA readiness. - Delivered ISO 11607, 11135/11137, 10993, F1980 packages usable in both 510(k) and MDR files. - Strong DHF/traceability; cross-functional drive with Engineering/Quality/Operations. - Working knowledge: ISO 13485, FDA QSR, ISO 14155, GCP, MDR/GSPRs, GUDID/EUDAMED. - Excellent technical writing, planning, and issue-closure. Engagement & Compensation - Salary Range: $100,000 – $120,000 base, depending on experience. - Benefits: Health, dental, vision, and standard employee benefits package. - Compliant with applicable laws; no applicant fees. 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. Seniority level - Mid-Senior level Employment type - Full-time Job function - Legal Industries - Medical Equipment Manufacturing #J-18808-Ljbffr

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