Glaukos – Sr. Global Product Surveillance Specialist How will you make an impact? The Sr. Global Product Surveillance Specialist is based in San Clemente, California, will be responsible for overseeing processes related to complaint and Medical Device Reporting (MDR) / Vigilance system; to ensure compliance and confirm that established processes are followed. The Medical Safety, Global Clinician, Nurse (RN) reviews reportability assessments and reports (i.e. MD - Rs, MDP - Rs, and Vigilance Repo... more details
Glaukos – Sr. Global Product Surveillance Specialist
How will you make an impact?
The?Sr. Global Product Surveillance Specialist is?based in San Clemente, California, will be responsible for overseeing processes related to complaint and Medical Device Reporting (MDR) / Vigilance system; to ensure compliance and confirm that established processes are followed. The Medical Safety, Global Clinician, Nurse (RN) reviews reportability assessments and reports (i.e. MDRs, MDPRs, and Vigilance Reports); to ensure that all complaints are properly evaluated for U.S. and international MDR/Vigilance reporting.?
What will you do?
MANAGEMENT OF COMPLAINT/MDR SYSTEM
Oversees processes related to complaint and Medical Device Reporting (MDR) / Vigilance system to ensure compliance and confirm that established processes are followed
Assists with standardizing process for assessing complaints for reportability
COMPLAINT INVESTIGATION/REPORTABILITY OF ADVERSE EVENTS
Approves reportability assessments and decisions
Responsible for maintaining clinical follow-up questionnaires
Ensures consistent decision rationales and risk assessment are documented in complaint files
Reviews complaint coding for accuracy
Reviews and approves device evaluations completed by the quality assurance and engineering??? team
Drafts and sends customer evaluation letters regarding complaint investigational findings
Oversees all aspects of the complaint investigation from opening to closure
Reviews complaint records for accuracy and completeness
TREND ANALYSIS
Assists with generating trend reports on complaints and adverse events as needed
Assists with regulatory report requests on complaints and adverse events as needed
Assists with monitoring trends and making recommendations when PPRA or CAPA is warranted
Assists with presenting trend reports at management review meetings as needed
Assists with participation in PPRA and CAPA team meetings as needed
PROCESS DEVELOPMENT
Assists with development and standardization of complaint investigations
Assists with reviewing standard operating procedures to ensure compliance with appropriate regulatory requirements
LEADERSHIP
Assists with training company employees on complaint/MDR regulations
Assists with training employees/contractors on complaint and Medical Device Reporting (MDR)/ Vigilance procedures
How will you get here?
Bachelor’s degree in nursing, or other health-related discipline and qualified to make a medical judgment (nurse, pharmacist, risk manager, or biomedical engineer)
Minimum 5 years relevant work experience in clinical, pharmaceutical or medical device industry. At least 1 year of experience with complaints MDRs, and adverse event reporting. Ophthalmology experience preferable
Experience in Regulatory Affairs and/or Quality Assurance in medical devices, previous complaint handling experience strongly preferred
Knowledge of regulation and standard affecting Medical Devices and Pharmaceuticals (i.e. ISO9001/13485/14971, FDA Regulations (21CFR (803, 806,820), JPAL, Medical Device Regulation (EU) 2017/745, Health Canada Medical Device Regulation, Australian Medical Device Incident Reporting &Investigation Scheme (IRIS), and Medical Device Single Audit Plan (MDSAP))
Ability to effectively communicate with customers and patients
Excellent written and verbal communication skills required due to frequent interaction with practicing ophthalmologists
Ability to manage reporting timelines
Ability to train employees on complaint and investigation requirements
Able to generate and analyze trends and identify when corrective action is needed
Excellent problem solving skills
Self-motivated and able to work independently, as well as within a team
Excellent organizational skills
Experience with medical and ophthalmology terminology
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