Sr. Global Product Surveillance Specialist

Company: ViziRecruiter,LLC.
Location: San Clemente
Posted on: May 22, 2023

Job Description:

Industry: Medical Technology and Pharmaceutical Level: Full time Location: San Clemente, CA Compensation: Base Salary Range: $82,500 - $119,500 Overview Compensation Compensation for each successful candidate will be based on several factors, which may include qualifications, experience, education, talent availability, and local market conditions. Range listed is not inclusive of additional compensation such as bonus, equity, or additional benefits. The Medical Safety, Global Clinician, or 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. Position Summary The Sr. Global Product Surveillance Specialist will be based in San Clemente, California, and will be responsible for overseeing processes related to complaint and Medical Device Reporting (MDR) / Vigilance system, ensure compliance, and confirm that established processes are followed. Compensation Compensation for each successful candidate will be based on several factors, which may include qualifications, experience, education, talent availability, and local market conditions. Range listed is not inclusive of additional compensation such as bonus, equity, or additional benefits. The Medical Safety, Global Clinician, or 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. Position Summary The Sr. Global Product Surveillance Specialist will be based in San Clemente, California, and will be responsible for overseeing processes related to complaint and Medical Device Reporting (MDR) / Vigilance system, ensure compliance, and confirm that established processes are followed. Compensation Compensation for each successful candidate will be based on several factors, which may include qualifications, experience, education, talent availability, and local market conditions. Range listed is not inclusive of additional compensation such as bonus, equity, or additional benefits. Responsibilities 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 Investig/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. 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. 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. Requirements Degree Bachelor's degree in nursing, or other health-related discipline and qualified to make a medical judgment (nurse, pharmacist, risk manager, or biomedical engineer). Knowledge 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)). Professional Self-motivated and able to work independently, as well as within a team. Experience 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. Experience with medical and ophthalmology terminology. Communication Ability to effectively communicate with customers and patients. Excellent written and verbal communication skills required due to frequent interaction with practicing ophthalmologists. Skills Ability to manage reporting timelines. Excellent problem solving skills. Excellent organizational skills. Ability to train employees on complaint and investigation requirements. Able to generate and analyze trends and identify when corrective action is needed. Degree Bachelor's degree in nursing, or other health-related discipline and qualified to make a medical judgment (nurse, pharmacist, risk manager, or biomedical engineer). Knowledge 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)). Professional Self-motivated and able to work independently, as well as within a team. Experience 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. Experience with medical and ophthalmology terminology. Communication Ability to effectively communicate with customers and patients. Excellent written and verbal communication skills required due to frequent interaction with practicing ophthalmologists. Skills Ability to manage reporting timelines. Excellent problem solving skills. Excellent organizational skills. Ability to train employees on complaint and investigation requirements. Able to generate and analyze trends and identify when corrective action is needed. About UsFounded in 1998, Glaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.Our company was the first company to bring to market Micro-Invasive Glaucoma Surgery (MIGS), the micro-invasive procedure which revolutionized the treatment and management of glaucoma. In 2012, we launched our first MIGS device-the iStent --in the United States, followed by our next-generation iStent -inject - -device in September 2018 and iStent -inject - -W in September 2020.In November 2019, Glaukos acquired Avedro, maker of the first and only FDA-approved cross-linking technology for progressive keratoconus. And we continue to seek to leverage our platform technologies to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies for glaucoma, corneal health, and retinal diseases. Legal Disclaimer: Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. view full text

Keywords: ViziRecruiter,LLC., San Clemente , Sr. Global Product Surveillance Specialist, Other , San Clemente, California