Post Market Quality Assurance Research

This position is part of the Quality Assurance team and is responsible for Post Market Surveillance (PMS) and Post Market Clinical Follow up (PMCF) activities for the assigned Natus Sensory Medical products. Primary responsibility of this position, but not exhaustive, is to uphold compliance.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• 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.
• 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).
• Performs comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature.
• 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 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.
• Clinical Evaluation in Hearing/Balance Medical Devices.
• Review/research applicable literature for product, conduct a clinical evaluation, and write reports.
• Working with regulatory industry standards such as QSR, ISO13485, MDSAP, MDR and China Regulations.
• Literature searches via platforms like Embase, PubMed and Google Scholar.
• All other duties as assigned based on changing market conditions, company and business needs.

EDUCATION AND/OR EXPERIENCE

• Bachelors degree in the health or life sciences.
• 3-4 years of industry experience in the Medical Device field.
• Post market surveillance report writing is essential.

EEO Statement
Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

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