Regulatory & Clinical Affairs Manager

SYLKE; Lima Metropolitana; On-site; PEN 353,857 - 424,628; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Standard employee benefits package

Job summary

A medical device company in Lima is seeking a Mid-Senior level Regulatory Affairs professional. You will manage pre-510(k) readiness and ensure compliance with regulatory standards for innovative medical products. The ideal candidate has 5+ years in the field and strong knowledge of FDA and ISO regulations. The role offers a competitive salary range of $100,000 to $120,000, along with comprehensive benefits.

Qualifications

• 5–8+ years in medical device regulatory affairs with end-to-end pre-510(k) readiness.
• Experience with ISO 11607, 11135/11137, 10993 packages for 510(k) and MDR.
• Strong cross-functional collaboration with Engineering and Quality.

Responsibilities

• Drive the pre-submission readiness for silk-fibroin products.
• Confirm FDA product codes and EU MDR class.
• Ensure compliance with ISO standards and FDA guidelines.

Skills

Regulatory Affairs

Clinical Evidence Coordination

ISO Standards Compliance

Technical Writing

Job description

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