Healthcare Specialist (Ophthalmology/Optometry)

1. Subject Matter Expert
2. Oversees Customer Quality Specialists under her span
3. Participates/presents during governance or business reviews as maybe required
4. Trains new team members as required
5. Medical Device Complaint Handling: Surgical Vision Care

• Complaint file management
  • Manage and process approximately 500 complaint files per month from the intraocular (IOL) product line, which can include literature complaints.
  • Perform file processing activities in a timely manner per Buyer’s policies and procedures, including coding, reportability determination for all relevant health authorities, and investigation determination.
  • Obtain relevant complaint information through product complaint follow-ups with maximum three attempts per Buyer’s policies. Enter complaint information into the Buyer complaint management system in a timely manner and in accordance with Buyer’s complaint management policies and procedures.
  • Close the complaint in accordance with Buyer’s complaint management policies and procedures.

• Regulatory reporting
• Generate/created regulatory reports as required for the event if determined reportable.
• Draft and submit approximately 70 regulatory reports from APAC region to the health authorities using the Buyer complaint management system
• Draft approximately 100 MIR monthly Vigilance reports from EMEA region
• Draft and/or Submit approximately 200 MDRs as defined by the Buyer
• Literature Review
• Literature articles are received via e-mail, direct communication from the customer, Buyer employees or through Buyer’s literature search team
• Performs literature article review using the Buyer complaint management system
• Performs the complaint entry and intake process resulting from the literature article reviews using the Buyer complaint management system for identified business unit of Buyer
• Conduct review of literature articles received and complete intake of new events or update existing records for additional information taken from the literature article reviews

• 3-5 years' of relevant experience in Ophthalmology or as an Optometrist
• Experience in Health Authority Reporting (Preferred)
• Experience in Medical Writing (Preferred)
• Experience in Medical Device Complaint Handling (Preferred)

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HMO Coverage with free dependent

Quarterly performance Bonus

Night Differential Pay at 20%