RA/QA Manager

Summary:

This position is responsible for ensuring our medical device’s compliance with all applicable regulations and maintaining the highest quality standards throughout the product lifecycle.

Responsibilities:

• Develop and maintain all necessary regulatory documentation, including product registrations, compliance reports, and technical files.
• Direct and oversee all device technical documentation activities and maintenance.
• Ensure timely preparation, review, and submission of regulatory filings to relevant agencies.
• Review and manage device lifecycle documentation.
• Support and facilitate compliance audits and interactions with regulatory authorities.
• Manage device labeling activities.
• Monitor and maintain up-to-date knowledge of evolving regulatory requirements and guidelines.
• Contribute to core compliance activities, such as CAPA, complaint handling, internal audits, and management review.

Qualifications:

• A minimum of 5 years of experience in QA and RA within the medical device industry.
• At least 3 years of specific experience working with invasive medical devices.
• Comprehensive understanding of ISO standards and international regulatory requirements, including MDD/MDR and FDA regulations.
• Demonstrated success in managing regulatory submissions and ensuring adherence to quality standards.
• Practical experience with routine QA/RA functions, including CAPA, complaint investigations, internal audits, and management review.