VP, Regulatory & Quality

San Carlos, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Robotics, HealthcareIndustries

Requirements

Candidates should possess a deep understanding of regulatory requirements, quality management systems, and a strategic mindset to drive continuous improvement initiatives. The role requires executive-level experience in regulatory affairs, quality management systems, and quality assurance. Experience in leading design control programs, developing post-market surveillance strategies, and managing risk management for hardware and software components is necessary. The ability to recruit, develop, and retain a high-performing team, foster a culture of accountability, and provide strategic guidance to leadership is also essential.

Responsibilities

The VP of Regulatory & Quality will oversee all aspects of regulatory affairs, quality management systems, and quality assurance to uphold product integrity and meet regulatory obligations. This includes staying abreast of regulatory requirements, developing and implementing compliance strategies, and representing the company in regulatory discussions and audits. The role involves establishing and maintaining robust QMS, leading design control programs, developing post-market surveillance strategies, and implementing risk management strategies for products and processes. Additionally, the VP will lead and manage a team of regulatory and quality professionals, foster a culture of continuous improvement, and collaborate with cross-functional teams.

Skills

Regulatory Affairs

Quality Management Systems

Quality Assurance

FDA Regulations

International Standards

Strategic Planning

Continuous Improvement

Risk Management

Audits

Inspections

Noah Medical

Develops medical robotic solutions for pulmonology

About Noah Medical

Noah Medical creates medical robotic solutions to improve early diagnosis in pulmonology. Their main product, the Galaxy System™ with TiLT+ Technology™, enhances diagnostic accuracy by providing real-time navigation and an augmented fluoro feature for locating lesions. The system is designed for efficiency with a single-use bronchoscope that reduces cross-contamination risks and improves workflow. Noah Medical stands out by collaborating with leading pulmonologists to ensure their technology meets practical clinical needs.

Redwood City, CaliforniaHeadquarters

2018Year Founded

$145.9MTotal Funding

SERIES_BCompany Stage

Robotics & Automation, HealthcareIndustries

201-500Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Mental Health Support

Legal Services

Pet Insurance

12+ Paid Holidays

15-20 Days of PTO

Paid Parental Leave

In-office Snacks and Beverages

In-office Lunch Stipend

Learning & Development Opportunities

Team Building and Company Organized Social Events

Hybrid Work Options

Risks

Increased competition from established companies like Intuitive Surgical in robotic bronchoscopy.

Potential delays in regulatory approvals could impact market entry and sales.

High cost of the Galaxy System™ may limit adoption in smaller healthcare facilities.

Differentiation

Noah Medical's Galaxy System™ offers real-time navigation updates for lung procedures.

The system's single-use bronchoscope reduces cross-contamination and improves procedural efficiency.

Compact design of the Galaxy System™ suits crowded bronch suites and operating rooms.

Upsides

Growing demand for minimally invasive procedures aligns with Noah Medical's focus.

Rising investment in healthcare technology startups offers funding opportunities for Noah Medical.

Advancements in AI enhance real-time image processing in Noah Medical's robotic systems.

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