Circadia Health is a medical technology manufacturer that has developed the world’s first FDA cleared the contactless remote patient system.
Powered by the worlds first FDA-cleared truly contactless patient monitoring system and AI, the technology monitors vital signs and bio-signals from up to 8 feet away without anything on the bed or body to identify medical events such as Congestive Heart Failure, COPD Exacerbations, Pneumonia, Sepsis, UTIs, and Falls several hours and days in advance.
A team of virtual nurses review data from the device and analyze trends in the patients electronic health record to deliver personalized, predictive risk alerts 24/7/365.
We’re looking for an innovative and solutions-oriented leader experienced in managing the Quality and Regulatory Compliance activities for medical devices in start-ups and large companies.
Experience successfully leading high-performing teams in fast-paced environments and providing strategic and technical guidance along with creating business solutions for quality systems, product development, operations, process improvement, and submissions.
Translates and scales quality system requirements appropriately for different medical device classes and provides practical and efficient solutions while assuring and maintaining regulatory readiness.
Direct experience leading audits with regulatory authorities (FDA, EMA, ANVISA) and responding to observations.
Experienced in Class I, II, III / 510k / PMA / NDA, including unique expertise in FDA expectations for software products and direct involvement in the creation of AAMI documents.
Requirements
FDA Quality Systems Implementation; Design Controls; Risk Management; ISO 14971; Verification & Validation; CAPA Implementation & Streamlining; Quality Assurance & Engineering; Supplier Quality; Management Review; Internal & External Audits; ATE & Test Equipment Validation; IQ/OQ/PQ; Domestic & International Regulations; Software Development Lifecycle (SDLC); Agile Software Development for Medical Devices; Contract Manufacturers; Document Control (TCE, Arena, Agile, paper-based); 21 CFR 820, 210, 211; 21 CFR Part 4 Combination Products; ISO 13485; MDD; TGA; Submission Deliverables; Complaints & Post Market Reporting; Corrections & Removals.
Benefits
* Health Care Plan (Medical, Dental & Vision)
* Retirement Plan (401k, IRA)
* Paid Time Off (Vacation, Sick & Public Holidays)
* Family Leave (Maternity, Paternity)
* Training & Development
* Work From Home
* Free Food & Snacks
* Wellness Resources
* Stock Option Plan
* Annual Company Retreat