Principal Quality & Regulatory Specialist

We are seeking a Principal-level Quality and Regulatory Affairs professional to lead and support global regulatory strategy and quality system compliance for a growing IVD organization. This is an excellent opportunity for a senior professional to contribute significantly to the company's global product growth.

Key Responsibilities:

• Serve as the in-house expert on global IVD regulatory submissions, including FDA 510(k), EU IVDR, Health Canada, APAC, and other international markets.
• Develop, execute, and manage regulatory strategies to ensure successful product registrations and compliance across global markets.
• Provide strategic guidance on regulatory requirements throughout the product lifecycle.
• Oversee and strengthen the Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and applicable international standards.
• Partner cross-functionally to support audits, inspections, and continuous improvement initiatives.
• Mentor junior staff and advise leadership on regulatory risk and quality best practices.

Qualifications:

• Proven experience in regulatory affairs and quality within the IVD or medical device industry.
• Successful track record with global submissions, including FDA, EU IVDR, and other international regulatory bodies.
• Deep knowledge of quality systems and standards (ISO 13485, QSR, etc.).
• Excellent communication and leadership skills.
• Advanced degree or RAC certification is a plus.

• Associate

• Full-time

• Quality Assurance

• Medical Equipment Manufacturing

This job is currently active and accepting applications.