Quality Compliance Specialist, MDR Reporting - Irvine

The Quality Compliance Specialist will evaluate global complaint information provided, · conduct additional investigation as needed and escalate as appropriate. · Evaluate complaints for Medical Device Reporting (MDR). Prepare · and submit MDR reports to FDA. · Assess complaint i ...

We are seeking a Senior Manager of Regulatory Affairs to lead regulatory strategy and execution for Class III cardiovascular medical devices. The ideal candidate has deep experience with PMA submissions, EU MDR requirements, and post-market activities within high-risk implantable ...

Responsible for timely preparation and submission of organized, scientifically valid global regulatory affairs submissions (clinical, pre-, and post-market applications), query responses and correspondence tracking. Maintains regulatory information for competitive intelligence, l ...

· We are searching for a Director of Regulatory Affairs with deep expertise in invasive electromechanical medical devices and extensive experience preparing and submitting 510(k) notifications. · Leads the preparation, submission, and negotiation of 510(k) premarket notification ...

The Director, Quality Customer Complaints provides strategic leadership and oversight of Masimo's global complaint handling process. · This position plays a critical role in shaping complaint strategy, identifying systemic risks and trends.Provide strategic direction for the glo ...

The Director, Quality Customer Complaints · provides strategic leadership and oversight of Masimo's global complaint handling process. This role is responsible for ensuring timely, consistent and accurate processing of customer complaints; driving cross-functional investigations; ...

The Clinical Research Specialist (CRS) is responsible for supporting and/or conducting clinical study activities and basic data collection at clinical sites. · Plan, implement and conclude clinical studies in support of project timelines/market release goals. · ...

Scientist 2, R&D will use knowledge of scientific techniques · to · contribute · to · validation · or · qualification · of reprocessed · in&nbspproducts. · ...

Johnson & Johnson MedTech Electrophysiology is recruiting for a Sr. Specialist, Scientific Operations to join the team in Irvine, CA or Raritan,NJ. · ...

We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. · Hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in ne ...

Job summary: · This position is with Johnson & Johnson MedTech Electrophysiology. · ...

Job Summary · JOB DESCRIPTION · The Clinical Research Specialist (CRS) is responsible for supporting and/or conducting clinical study activities and basic data collection at clinical sites, as well as managing assigned clinical projects & operations, including pre-monitoring acti ...

The Clinical Research Specialist (CRS) is responsible for supporting and/or conducting clinical study activities, · Plan, implement and conclude clinical studies in support of project timelines/market release goals. · Prepare and document study plans, contracts, budgets... · ...

The Senior Manager of Regulatory Affairs will lead regulatory strategy and execution for Class III cardiovascular medical devices including stent implantable technologies This role is responsible for global regulatory submissions lifecycle management post market regulatory compli ...

Sr. Regulatory Affairs Specialist responsible for providing strategic input and technical guidance on product lifecycle planning and regulatory requirements. · ...

We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. · ...

Coordinate the receipt and evaluation of product complaint samples. · Receive product complaints and samples from customers, sales representatives, distributors and FDA. · Enter complaints into the computerized Product Incident Report (PIR) database to ensure their traceability. ...

The TSK Group operates globally in medical technologies. Our focus is on innovation that supports both practitioner performance and patient experience—through constant iteration, smart engineering, and attention to detail. · Serve as the principal advisor to the President and Exe ...

We're hiring a QARA Manager with hands-on medical device QA/RA experience to lead and harmonize our global Quality and Regulatory program. · This role is accountable for ensuring our QMS and regulatory compliance are effective across regions, supporting audits/certifications, gui ...

The Medical Affairs Analyst will be a key member of the Office of the Chief Medical Officer (CMO) and serve an important role in building MicroPort's unified medical and evidence infrastructure. · This is an ideal role for a scientifically trained, detail oriented, and articulate ...