Post Market Quality Associate

Job description

FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body’s signals. Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for everyone who wants to be part of the innovative solutions at Natus Neuro. JOB TITLE: Post Market Quality Associate DEPARTMENT: Regulatory/Clinical Affairs EXEMPT: Y: 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, wri...