Amick Brown is seeking an experienced Regulatory Post Market Surveillance Coordinator for our direct client. Location: Remote Duration: 1 Year
The Regulatory Post Market Surveillance Coordinator investigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.
Roles and Responsibilities Investigating complaints daily
Perform the preliminary classification of complaints and escalate complaints that require additional review.
Perform Failure Analysis investigation review and escalate complaints that require additional review.
File Malfunction MDR Reports as identified
Escalate Adverse Event or Incident reports as identified
Evaluate documentation for completeness and consistency, and assign additional actions as necessary to close the complaint file.
Approve final complaint file for closure after all applicable actions are completed.
Manage complaint workload to required backlog goals.
Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered
Escalate complaints to the Post Market Investigation (PMI) group as required
Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
Create customer response letters as needed
Provide peer review and feedback of complaints and reports
Participate in new hire training and continuous Regulatory Compliance training as required
Participate in process improvement activities to continuously improve process effectiveness
Execute on projects as required
Perform other duties as directed
Education - Undergraduate degree in engineering, life science, or equivalent
Experience – 1+ years of experience in medical device field, with experience or exposure in the following areas:
Knowledge and basic understanding with Medical Device Complaint files and quality record documentation
Knowledge and basic understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
General technical and or clinical medical device knowledge
Skills: The following skills are required for this position:
Demonstrate strong written and verbal communication skills
General computer skills (Excel, Word, PowerPoint, database)
Efficient independent worker with ability to focus
Attention to detail
Demonstrate cross functional communication skills in email and in person
Organizational and analytical skills
Ability to handle and manage workload independently
Prioritize numerous activities in a rapid paced environment
Contribute to team oriented tasks
Interpersonal and decision making skills.
Detail oriented and strong administrative skills including time management.
Competency / Training: The following competencies are essential for this position:
General and basic understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements for post market surveillance.
General and basic understanding of quality records requirements and how they apply to complaint files and regulatory reports.
Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.
Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.
Regular full-time employees are eligible for the following Amick Brown provided benefits: