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