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Principal Regulatory Affairs Specialist

Capstan Medical · Santa Cruz, California · Hybrid

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About Capstan Medical

Backed by Eclipse Ventures.

About the role

Come join us and become part of a team revolutionizing heart valve treatment! Found on 1752vc Careers, the job board for startup and VC roles.

What they're looking for

  • Bachelor’s degree in Regulatory Science, Biomedical Engineering, Life Sciences, or a related technical discipline
  • Minimum 6 years of progressive and successful regulatory affairs experience in the medical device industry, Class III long-term implantable, software, and/or robotics experience is preferred
  • Strong experience supporting submissions for high risk, novel medical devices
  • Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment
  • Ability to leverage and/or engage others to accomplish projects
More about this role

At Capstan Medical, we are driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we have pioneered a patient-optimized approach to repair and replace heart valves.

Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients with a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.

Capstan Medical is uniquely positioned in Santa Cruz, CA; this gives us access to the amazing technical talent of the Bay Area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from...

Read the full posting on Capstan Medical's site ↗

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