Regulatory & Clinical Affairs Manager, MedTech Wound Care

SYLKE; Lima Metropolitana; Presencial; PEN 353.857 - 424.628; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

Dental insurance

Vision insurance

Standard employee benefits package

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory Affairs

Clinical Evidence Coordination

ISO Standards Compliance

Technical Writing

Descripción del empleo

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.