- Locations: California, Minnesota, New Jersey, Massachusetts, Utah
- Related Keywords: Device
- Sr. Post Market Quality Manager
- Business Services Company (Minneapolis, MN)
- ...directly with Physician complaint review boards And extensive knowledge with requirements to maintain national and international practices, guidance, standards, and regulations. KEYWORDS: Medical Device , Quality, vigilance ,CFR,ISO,implantable clinical device , compliant metrics
- Senior Clinical Scientist
- Evalve Inc (Menlo Park, CA)
- ...clinical protocols, provide guidance to R&D teams, and support vigilance review of commercial product as needed. Bachelor of...Level or Doctorate level preferred (Medical, Veterinary, or Biological sciences). 2-5 Years experience in cardiovascular medical device industry...
- VP, Regulatory Affairs Cardiovascular Med Device San Diego
- Unknown (Irvine, CA)
- ...agencies. * Interface with domestic and international regulatory agencies. Comply and maintain Primary Corporate contact, Medical Device Reports (MDRs) & Vigilance Reports. * Demonstrate knowledge of competitive studies for peripheral arterial disease. Knowledge of Heart Disease is...
- Quality Assurance Analyst
- Stryker (Mahwah, NJ)
- ...engineers to determine reportability. . Review PERs for reportability to the FDA and other competent authorities under Medical Device Reporting and Medical Device Vigilance Regulations. . Ensure timely completion of MDR/MDV rationales and initial, supplemental, and final incident...
- Quality Assurance Analyst
- Stryker (Portage, MI)
- ...engineers to determine reportability. Review PERs for reportability to the FDA and other competent authorities under Medical Device Reporting and Medical Device Vigilance Regulations. Ensure timely completion of MDR/MDV rationales and initial, supplemental, and final incident...
- Quality Assurance Analyst
- Stryker (Mahwah, NJ)
- ...engineers to determine reportability. ? Review PERs for reportability to the FDA and other competent authorities under Medical Device Reporting and Medical Device Vigilance Regulations. ? Ensure timely completion of MDR/MDV rationales and initial, supplemental, and final incident...
- Sr. Post Market Quality Manager
- Business Services Company (Minneapolis, MN)
- ...directly with Physician complaint review boards And extensive knowledge with requirements to maintain national and international practices, guidance, standards, and regulations. KEYWORDS: Medical Device , Quality, vigilance ,CFR,ISO,implantable clinical device , compliant metrics
- Sr. Post Market Quality Manager
- Unknown (Minneapolis, MN)
- ...directly with Physician complaint review boards And extensive knowledge with requirements to maintain national and international practices, guidance, standards, and regulations. KEYWORDS: Medical Device , Quality, vigilance ,CFR,ISO,implantable clinical device , compliant metrics
- Sr. Post Market Quality Manager
- MRI Networks (Minneapolis, MN)
- ...complaint review boards & And extensive knowledge with requirements to maintain national and international practices, guidance, standards, and regulations.& & & KEYWORDS: Medical Device , Quality, vigilance ,CFR,ISO,implantable clinical device , compliant metrics
- Quality Assurance Complaint Analyst
- Stryker (Mahwah, NJ)
- ...engineers to determine reportability. Review PERs for reportability to the FDA and other competent authorities under Medical Device Reporting and Medical Device Vigilance Regulations. Ensure timely completion of MDR/MDV rationales and initial, supplemental, and final incident...
- Regulatory Compliance Engineer
- Intuitive Surgical, Inc. (Sunnyvale, CA)
- ...in US FDA Medical Device Reporting, and Corrections and Removals regulations * Expertise in the European Medical Device Directive and vigilance reporting requirements * Expertise in Canadian Medical Device applications and reporting requirements * Certified Quality Auditor (ISO...
- Senior Regulatory Compliance Engineer
- Surgical Intuitive, Inc. (Sunnyvale, CA)
- ...in US FDA Medical Device Reporting, and Corrections and Removals regulations * Expertise in the European Medical Device Directive and vigilance reporting requirements * Expertise in Canadian Medical Device applications and reporting requirements * Certified Quality Auditor (ISO...
- Product Surveillance Specialist
- Bausch and Lomb (Aliso Viejo, CA)
- ...of travel Qualifications .Bachelor's degree required with 3-5 years related work experience..Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs & ISO requirements for medical devices preferred..Position requires strong...
- Senior Product Surveillance Specialist
- Bausch and Lomb (Aliso Viejo, CA)
- ...degree is required, plus a minimum of 5-7 years related work experience..Knowledge of ophthalmic medical terms, Medical Device Reporting regulations, Vigilance reporting regulations, GMPs & ISO requirements for medical devices preferred..Position requires strong...