Medical Device Regulatory Compliance Specialist

OverviewThe Private Medical Device Company is a pioneering organization dedicated to revolutionizing emergent neurosurgical procedures. Our mission is to deliver cutting-edge, FDA-cleared medical devices that improve patient safety and efficacy.

RequirementsWe are looking for a highly organized individual with excellent communication skills and attention to detail. The ideal candidate will have 5+ years of experience in regulatory affairs and/or quality management, preferably in the medical device industry.Required qualifications include:Bachelor's degree in Engineering, Life Sciences, or a related...

Key ResponsibilitiesDevelop and execute regulatory strategies to support product development and market approval across domestic and international markets.Prepare, review, and submit regulatory filings (e.g., 510(k), Letter to File, ISO certifications) to ensure timely product approval.Stay up-to-date with changing global regulations and industry standards...

Job SummaryOur Private Medical Device Company is seeking a Quality Management and Regulatory Strategy Leader to develop and implement effective quality management systems and regulatory strategies.The successful candidate will have a deep understanding of regulatory frameworks, quality management systems, and industry standards related to medical devices.Key...

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