Quality and Regulatory Manager

Quality and Regulatory Manager responsible for owning, maintaining, and continuously improving the ISO 13485 Quality Management System while supporting regulatory activities for existing and new medical device products.

Requirements

• Bachelor's degree in Engineering, Science, or a related technical discipline.
• 4+ years of experience in quality and regulatory roles within the medical device industry.
• Strong working knowledge of ISO 13485 and FDA Quality System Regulation.
• Demonstrated experience leading audits and managing regulatory inspections.
• Proven ability to manage and improve a QMS in a hands-on environment.
• Strong documentation, organizational, and communication skills.
• Ability to work independently and exercise sound judgment in a regulated setting.

Benefits

• Competitive compensation package
• Full benefits
• Paid vacation