Jobs and Careers

Lead Post Market Surveillance Specialist

United Statesfull_timeVerifiedPosted 16 Apr 2025

💰 $127,000/yr($116,000/yr – $127,000/yr)

About the role

Title: Lead Post Market Surveillance Specialist
This position is based in our Campbell, California offices. This position is on-site, full-time.

Why Imperative Care?
Do you want to make a real impact on patients?
As part of our team at Imperative Care, you can help elevate care for patients suffering from stroke and other devastating vascular diseases. Every day, the technologies that we develop at Imperative Care directly impact people at the most vulnerable moments of their lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do
An individual in this role uses advanced expertise to oversee activities for monitoring the Complaints and Post Market Surveillance System, conducting complaint intake activities, assessing regulatory reporting, leading complaint investigations, submitting regulatory reports, maintaining quality compliance, and achieving quality metrics in areas of responsibility. This position will collaborate directly with customers, Regulatory Agencies, Notified Bodies, and requires extensive knowledge of industry practices, techniques, and standards.

Ensure compliance of the Complaints System to internal requirements and applicable Regulations.
Establish and report on complaint trends with actions for resolution.
Review adverse event reporting determinations against applicable regulatory requirements (FDA, EU MDD/MDR, PMDA, TGA etc.).
Complete reportability assessment and route for approvals in a timely manner.
Accurately assess risk and escalate high risk incidents to appropriate management.
Complete and submit applicable regulatory reporting documents in an accurate and timely manner.
Determine if an investigation is necessary. Support investigation activities as necessary for complaints processing/closure in a uniform and timely manner. Determine potential cause and contributing factors to the alleged event, device relationship, and whether formal device investigation is necessary.
Conduct complaint investigations using concise and grammatically correct language appropriate for regulatory review.
Develop, maintain, and improve procedures for device failure analysis.
Perform timely, methodical failure analyses of devices, including failure replication to determine cause of device failure.
Ensure complaints are closed in a timely manner and in compliance with FDA and other regulatory requirements
Ensure complaints are prioritized based on patient, product, and compliance risk.
Communicate with Customers and field reps in a professional manner to gather complaint information.
Assist with training Customers and field reps to ensure compliance to Post Market Surveillance requirements.
Ensure Adverse Event Reporting regulatory guidance documents are available prior to product launch in the required/applicable? geographies.
Develop and implement complaint event tracking and trending data collection tools.
Work cross-functionally to compile and generate periodic reports in a timely manner to support Post Market Surveillance activities.
On an ongoing basis, monitor adequacy of the Complaints, Post Market Surveillance and Recalls System, and identify and implement system improvements.
Draft new procedures and system changes as needed to accommodate regulatory requirements for new country introductions.
Ensure the Post Market Surveillance Systems are tied to Risk Management process