Regulatory Affairs & Quality Manager - Remote

Overview

The Regulatory Affairs & Quality Manager plays a crucial role within the Regulatory Affairs department, responsible for maintaining and improving certifications such as ISO 13485, overseeing the Quality Management System (QMS), and ensuring compliance with relevant standards and regulations.

In Short

• Interface with FDA and international regulators.
• Maintain knowledge of ISO standards.
• Coordinate regulatory compliance for new products.
• Oversee QMS management and internal audits.
• Develop and deliver QMS training materials.

Requirements

• 3+ years of medical device regulatory experience.
• Bachelor's degree in a related field.
• Knowledge of ISO 13485 and ISO 27001 standards.
• Proficiency in MS Office and Google Suite.
• Strong communication skills in English.

Benefits

• Confidentiality of applicant information.
• Equal employment opportunity commitment.