Job Description
Location: Bothell, WA • Cambridge, MA • Plymouth, MN (Hybrid – 3 days onsite)
Are you a clinical science expert ready to impact the future of ultrasound technology? Join our innovative team as a Senior Clinical Development Scientist and lead the strategy, execution, and documentation of clinical studies that drive regulatory success and patient outcomes.
Key Responsibilities:
* Design and lead clinical studies (pre-market and post-market) for ultrasound products.
* Develop protocols, CSRs, CERs, and regulatory documentation to support FDA and international submissions.
* Collaborate with cross-functional teams (R&D, Regulatory, Medical Affairs, Market Access).
* Engage with investigators, IRBs, and global regulatory agencies (FDA, EMA, NMPA).
* Analyze clinical data, support health economics evidence, and drive publication strategy.
Ideal Candidate Has:
* PhD or MD in a relevant scientific field (required).
* 7+ years in clinical research or development, preferably with medical devices.
* Strong experience designing clinical studies for regulatory environments (FDA, EU-MDR).
* Solid understanding of GCP, design controls, and product development processes.
* Excellent writing and communication skills in English for scientific documentation.
* Experience with ultrasound and/or AI-driven clinical validation (a plus).
* Based near one of the required offices with ability to work onsite 3 days/week.
Why Join Us?
* Help shape the next wave of ultrasound innovation.
* Collaborate with thought leaders and make an impact globally.
* Competitive salary, benefits, and opportunities for growth.
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