Qureos Mentor

Noctrix Health, Inc.

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 Noctrix Health is redefining the treatment of chronic neurological disorders with clinically validated therapeutic wearables. Our team of medical device specialists, neuroscientists, and consumer electronics engineers is dedicated to delivering prescription-grade therapy with an outstanding user experience. We have pioneered the world's first drug-free wearable therapy, clinically proven to alleviate symptoms in adults with drug-resistant Restless Legs Syndrome (RLS). Be part of our mission to transform healthcare, improve lives, and drive meaningful change with Noctrix Health.
 
 
 
 
 
 The
 
 Clinical Scientist
 
 will support regulatory, quality, and scientific activities across the Nidra product lifecycle. This role is ideal for a recent PhD graduate in a science or engineering discipline who is eager to contribute to regulatory documentation, clinical data analysis, and compliance activities. The Clinical Scientist will collaborate cross-functionally with Regulatory Affairs, Quality, R&amp;D, Research and Marketing to ensure high-quality regulatory and scientific submissions supporting product development and commercialization.
 
 
 This position reports to the Senior Vice President, Clinical and Regulatory Affairs.
 
 
 
 
 
 
 Responsibilities:
 
 
 
 
 
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 Clinical Evaluation &amp; Post-Market Surveillance: Conduct literature reviews and develop or update Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) reports
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 Regulatory Documentation: Prepare, review, and maintain regulatory submissions, technical documentation, and product labeling in compliance with applicable requirements (e.g., 510(k), De Novo, EU MDR/IVDR)
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 Medical Device Reporting (MDR): Assess and evaluate complaints for Medical Device Reporting compliance, ensuring timely reporting to regulatory authorities
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 Promotional Review: Review marketing and promotional materials to ensure compliance and prevent off-label promotion
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 Product Development Support: Assist in preparing technical documentation, labeling, Regulatory Assessments and Instructions for Use (IFUs) for new product introductions and design modifications
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 Clinical Trial &amp; Public Registry Management: Update and maintain study information on clinicaltrials.gov in accordance with regulatory requirements
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 Data Analysis &amp; Reporting: Compile, analyze, and interpret scientific, clinical, and quality data; create datasets, dashboards, and reports for regulatory, quality, and executive audiences
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 Regulatory Interactions: Support communications with regulatory authorities by preparing briefing materials and ensuring consistency across scientific and technical documentation
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 Regulatory Strategy: Contribute to planning global submissions and post-market compliance activities, ensuring alignment with business objectives
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 Cross-Functional Collaboration: Partner with Quality, Clinical Affairs, and other teams to maintain compliance with internal and external standards (e.g., ISO 13485, 21 CFR 820, GCP, ISO 14155)
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 Issue Identification &amp; Resolution: Proactively identify potential regulatory issues and support the development of effective, compliant solutions
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 Systems Oversight: Assist in developing and maintaining systems for tracking regulatory commitments, submissions, and post-market follow-up activities
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 Requirements:
 
 
 
 
 
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 PhD in Biomedical Engineering, Life Sciences, or a related scientific field (required)
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 0&ndash;2 years of relevant industry or regulatory experience (medical device experience preferred)
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 Strong understanding of regulatory principles and frameworks (FDA, EU MDR/IVDR, ISO 13485, ISO 14155)
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 Excellent scientific and technical writing skills; demonstrated ability to interpret and present data effectively
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 Experience compiling and analyzing data for regulatory, quality, or clinical purposes
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 Detail-oriented with strong analytical, problem-solving, and organizational skills
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 Proven collaboration and communication skills across cross-functional teams.
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 Self-motivated, capable of working independently in a fast-paced, compliance-driven environment
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 Compensation:
 
 
 
 
 
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 Base pay: $100,000&ndash;$130,000 per year + bonus + stock options
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 This is a full-time, hybrid position located in our Pleasanton Headquarters. We require an in-office presence of at least 2-3 days per week.***
 
 
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Clinical Scientist

Join Noctrix Health, Inc. and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Noctrix Health, Inc.

ABOUT_COMPANY

Clinical Scientist