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Medical Devices Regulatory Compliance Specialist

vor 1 Monat


Munich, Bayern, Deutschland SciPro Vollzeit
About SciPro

SciPro is a fast-growing startup dedicated to fighting skin cancer with innovative products.

Job Overview

This role offers an exciting opportunity to maintain and oversee compliance with quality systems, optimize global QA/RA processes, and ensure regulatory requirements are met.

Key Responsibilities
  • Maintain and improve compliance with quality systems to ensure regulatory requirements are met.
  • Optimize global QA/RA processes to enhance efficiency and effectiveness.
Requirements
  • 3-5 years of experience in quality management and regulatory affairs for medical devices.
  • Experience with FDA regulatory submissions (510k), quality management systems (ISO 13485/21 CFR 820) & risk management (ISO14971).
  • Fluent English required.
What We Offer

$120,000 - $150,000 per annum. Competitive salary range based on industry standards, location, and experience.