Marketing Compliance Manager
Omada Health- Full Time
- Entry Level & New Grad
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.
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.
Develops medical robotic solutions for pulmonology
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.