Senior Clinical Safety Monitor

Senior Clinical Safety Monitor

Remote

As a TEAMMATE:

If you are looking for a challenging opportunity to work in an international environment, then look no further. Welcome to Natus Medical. We're a group of go-getter It's easy to get hyped when you're serving the diverse needs of everyone from neurosurgeons to babies. Join us! We are looking for a Lead Clinical Safety Monitorto join ourClinical Affairsorg that spans a diverse product portfolio in the nervous and sensory system disorder area.

What you'll get to do in this role:

• Write and edit PMS Plans/Reports, PMCF Plans/Reports and Clinical Evaluation Plans/Reports to meet MDR and China requirements for each product family.
• Schedule and lead PMS, PMCF and Clinical Evaluation Review Meetings for each product.
• Collect essential documents for Post Market Clinical Follow up and Investigator Initiated Trials, review for completeness and compliance with Standard Operating Procedures, the protocols and appropriate regulations.
• Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such Clinical Education, Sales and Marketing, Quality Engineering and Risk Management)
• 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.
• Travel: up to 15% domestic or international travel, on project need basis
• Work Location: Remote

What we are looking for:

• Bachelor's degree in the health or life sciences.
• 6-8 years' of industry experience in the Medical Device field.
• Clinical Evaluation experience in Neurology and Hearing/Balance Medical Devices.
• Must be able to review/research applicable literature for product, conduct a clinical evaluation, and write the reports.
• Possess a good working knowledge of regulatory industry standards such as QSR, ISO13485, MDR and China Regulations.
• Experienced at performing literature searches via platforms like Embase, PubMed and Google Scholar.
• Strong multi-tasking ability. Must be able to transition to different priorities quickly and efficiently
  

Compensation and Benefits: Along with a competitive salary and bonus structure, we offer a comprehensive benefit package to include: Health Benefits, 401k match, paid holidays 2 floaters, and 4 weeks PTO (accrued). All of our benefits start on day 1!

Natus Transparency Details The pay range for this position is 135-145K annually. The actual base pay offered may vary depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. At Natus, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

We are PASSIONATE about:

Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose and treat disorders of the brain, neural pathways and sensory nervous system . Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life. Natus products are used in hospitals, clinics and laboratories worldwide.

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.

Come Join natUS!

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