Product Surveillance Analyst II

About the Role

Key Responsibilities

• Perform electronic record management and regulatory reporting within complaint handling.
• Investigate reports of worldwide product events and enter information into the database.
• Independently determine and file appropriate medical device reports with regulatory agencies.
• Manage high volume record intake and electronic submission of regulatory reports.
• Communicate effectively with employees, customers, and external clients/sales reps.
• Fill in templated forms for reporting bodies in various countries.

Requirements

• Bachelor's Degree in a science-related field.
• 2+ years of experience in post-market surveillance, medical device, or pharmaceutical industry.
• Strong problem-solving skills.
• Proficient at navigating computer systems.
• Experience in investigations, medical device reporting, or product evaluation.
• Writing experience.

Nice to Have

• Previous knowledge of global regulations for medical device reporting.
• Medical terminology knowledge.
• Experience in OUS regulatory reporting or MDR.

Benefits & Perks

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)