Noah Medical

Manager, Complaints and Post-Market

United States

Noah Medical Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries

Requirements

The ideal candidate should possess a Bachelor's degree in a relevant scientific or technical field, along with a minimum of 7 years of experience in post-market surveillance, complaint handling, or regulatory affairs within the medical device industry. Demonstrated knowledge of quality systems, regulatory requirements (e.g., MDR, FDA), and adverse event reporting is essential. Strong analytical and problem-solving skills are also required, as is the ability to interpret and apply regulatory guidelines.

Responsibilities

As the Manager, Complaints and Post-Market, you will perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements, oversee the day-to-day activities of the complaint handling team, work closely with Product Quality Engineering to complete investigations and complaints, manage adverse event reporting activities, submit reports to regulatory authorities, manage complaint metrics and analytics, schedule post market surveillance reviews, coordinate with various teams to gather information, initiate risk file updates, review customer inquiries, identify and escalate complaints, perform case final reviews, and manage complaint handling team activities while reviewing and creating SOPs and WIs.

Skills

Regulatory compliance
Complaint handling
Quality assurance
Investigation management
Team oversight
Process review

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.

Key Metrics

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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