Post Market Quality Associate

JOB TITLE: Post Market Quality Associate

DEPARTMENT: Regulatory/Clinical Affairs

EXEMPT: Y

EMPLOYEE NAME:

SUPERVISOR:

LOCATION: Remote US

SUMMARY:

As part of the QARA team, responsible for Post Market Surveillance (PMS) and Post Market Clinical Follow up (PMCF) activities for the assigned Natus Neuro Medical products. Primary responsibility of this position, but not exhaustive, is to uphold compliance to ISO13485, MDD 93/42/EEC, MDR 2017/745, FDA 21CFR Part 820, Canadian SOR-98-282, Australian Regulatory Guidelines for Medical Devices (ARGMD), Brazil ANVISA Medical Device Regulations, and the Japanese PMDA regulations where applicable in relation to Post Market Surveillance., within the Natus neuro Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Define, write and edit PMS Plans/Reports, PMCF Plans/Reports and to meet global regulatory requirements for each product family.
• Schedule and lead PMS, PMCF meetings for each product.
• Collect essential information and documents for Post Market Clinical Follow up, review for completeness and compliance with Standard Operating Procedures, associated protocols and appropriate regulations.
• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Clinical, Sales and Marketing, Quality Assurance and Risk Management and Regulatory Affairs)
• Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
• Support product development and design history files activities as per Quality Management System.
• Stay up-to-date and follow all the Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
• Participates on other special clinical projects as required.
• Participate in regulatory audits and defend PMS documentation and provide draft responses for questions from Notified Bodies.
• All other duties assigned based on changing market conditions, company and business needs.

SUPERVISOR RESPONSIBILITIES

N/A

QUALIFICATION REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE:

• Bachelor's degree in the health or life sciences.
• 2-3 years of industry experience in the Medical Device field.
• Post market surveillance report writing is essential.
• Knowledge on EU MDR post market requirements.
• Strong multi-tasking ability and must be able to transition to different priorities quickly and efficiently.
• Possess a good working knowledge of regulatory industry standards such as QMSR, MDSAP, and EU MDR.