Manager - Complaints and Post-Market

April 10

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $120k - $140k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

🦅 H1B Visa Sponsor

Apply Now

Receive Emails with Similar Jobs

Noah Medical

WebsiteLinkedInAll Job Openings

Noah Medical is a company pioneering the next generation in medical robotics, specifically focused on interventional pulmonology. They have developed the Galaxy System™ featuring TiLT + Technology™, designed to overcome challenges such as CT-to-body divergence in medical procedures. Their proprietary technology facilitates real-time navigation updates and guidance within the lung, aiming for earlier and more confident diagnosis. The system utilizes a single-use bronchoscope to reduce cross-contamination risks and improve procedural efficiency. Noah Medical collaborates with leading healthcare professionals to deliver solutions that integrate seamlessly with existing medical equipment, enhancing diagnostic accuracy and procedural outcomes.

201 - 500 employees

Founded 2018

⚕️ Healthcare Insurance

💰 $150M Series B on 2023-04

📋 Description

• Perform a wide variety of activities to ensure compliance with applicable quality and regulatory requirements. • Oversee day-to-day activities of the complaint handling team, ensuring complaints are handled promptly and accurately. • Work closely with Product Quality Engineering team to ensure that investigations and complaints are completed and closed out in a timely manner. • Review complaint files to ensure all complaint elements have been addressed and properly documented within the complaint file. • Manage adverse event reporting activities including decision rationale and reporting documentation. • Submit adverse event reports to regulatory authorities. • Manage complaint metrics and analytics including trending and measure against statistical trend limits. • Schedule post market surveillance reviews and complete post market surveillance reports based on applicable regulatory requirements. • Coordinate with clinical, marketing, sales, regulatory, and R&D to obtain their respective post market surveillance information based on regulatory requirements. • Initiate risk file updates based on post market data such as complaint rates and new hazards. • Review customer inquiries and service reports for potential complaints. • Identify and escalate complaints for potential adverse event reporting decisions. • Perform complaint case final reviews for closure. • Manage complaint handling team activities and provide guidance as needed. • Review, revise and create SOPs (Standard Operating Procedures) and/or WIs(Work Instructions) related to complaint handling, adverse event reporting. • Prepare SOPs and WIs and gather data as needed to support ISO 13485:2016 clause 8.2.1 Feedback and for OUS regulatory requirements. • Assist in audits (internal and external). May also conduct internal audits as needed. • Other QMS activities as assigned.

🎯 Requirements

• At minimum a BS degree in a technical field such as engineering, computer science, or a science related discipline. • 5+ years of complaint-handling experience in the medical device industry. • Ability to manage others, their work, and your own multiple competing priorities. • Working knowledge of the entire complaint handling process from intake, investigation, closure, and reportability assessments. • Strong Working knowledge of US FDA 21 CFR 820.198, 803, and 806 requirements. • Basic Working knowledge of OUS adverse event reporting requirements. • Basic Working knowledge of OUS post market surveillance requirements. • Working statistical knowledge as it pertains to trending Intermediate understanding of mechanical and software aspects of medical devices.

🏖️ Benefits

• Competitive Salary • Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options • Equity & Bonus Program • Life Insurance (company paid & supplemental) and Disability insurance • Mental health support through medical insurance programs • Legal and Pet Insurance • 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days • Paid parental leave • In-office snacks and beverages • In-office lunch stipend • Learning & Development Opportunities: On-demand online training and book reimbursement • Team building and company organized social and celebration events