Head of Regulatory Affairs

2 days ago

Santa Cruz, United States Capstan Medical Full time

Overview:


Capstan Medical:

Creating a new standard for minimally invasive structural heart treatment.


At Capstan Medical, we’re 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’ve 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 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, 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 the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.


Come join us and become part of a team revolutionizing heart valve treatment.


Sr. Director/VP, Regulatory Affairs (depending upon experience)


Reports to: CEO


Description:

This is a unique opportunity for an experienced Regulatory Affairs leader to join a well-

funded, early-stage start-up positioned to revolutionize structural heart care. This ground floor

role will be part of building and executing on the regulatory strategy for novel implants,

catheters and a robotic platform.


Responsibilities:

  • Acts as a regulatory representative on core product development teams, communicates
  • regulatory requirements and impact of regulations to project teams, and provides input
  • related to FDA and international product registrations and licensing requirements
  • Establishes and executes regulatory strategy in partnership with leadership, product and
  • clinical teams
  • Prepares, reviews, approves & submits Pre-Market Approval documents as well as
  • 510(k)s, IDEs, HUDs, etc Prepares and submits PMA and IDE Submissions and
  • Supplements
  • Works with international affiliates to compile and submit international product
  • registrations and licensing applications
  • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures
  • Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations
  • Maintains annual licenses, registrations, and listing information
  • Assists with compliance to product post-marketing approval requirements
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Reviews protocols and reports to support regulatory submissions
  • Acts as liaison between the Company and the various regulatory agencies
  • Interfaces directly with FDA and Notified Bodies
  • Reviewing product design and manufacturing changes to assess regulatory impact and completing any associated regulatory activities


Skills:

  • Ability to identify critical path activities and articulate and mitigate risks to clinical trial
  • conduct
  • Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the
  • conduct of clinical trials
  • Experience in Class 3 implantable devices, cardiovascular implants preferred
  • Strong communication skills, both verbal and writing
  • Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute
  • on goals as a member of an interdisciplinary team is extremely important
  • Highly collaborative and comfortable in a hybrid work environment


Requirements:

  • BS/MS Degree in a scientific discipline with a minimum of 10 years of regulatory
  • experience in the medical device industry
  • Experience in breakthrough designation a plus
  • Some travel expected

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