Job Description

Noah Medical is seeking a VP of Regulatory and Quality to ensure compliance with regulatory standards and maintain high quality within the organization. This role involves developing and implementing regulatory strategies, overseeing quality management systems, leading quality assurance initiatives, managing risk, and fostering a culture of continuous improvement. The ideal candidate will have extensive experience in the medical device industry and a strong understanding of regulatory requirements.

Responsibilities

• Ensure regulatory compliance
• Establish and maintain quality management systems
• Lead Design Control program
• Develop post-market surveillance strategies
• Identify and assess regulatory and quality risks
• Recruit, develop, and retain a high-performing team
• Collaborate with cross-functional teams
• Drive continuous improvement initiatives

Requirements

• Bachelor's degree in a relevant scientific or engineering discipline
• Extensive experience in regulatory affairs and quality management
• Proven track record of successful regulatory submissions
• In-depth knowledge of regulatory requirements and standards
• Strong understanding of quality management systems
• Excellent leadership and communication skills
• Strategic mindset
• Experience building and leading teams

Benefits

• No benefits