Head of Regulatory & Clinical Affairs

Eximis Surgical
Remote (US)
Specimen segmentation and removal
Louisville, CO
11-50 Employees


Eximis Surgical is developing a laparoscopic specimen removal system for minimally invasive surgery (MIS) designed to fully contain specimen segmentation and removal. Eximis secured $8.7M in financing from Olympus Innovation Ventures to fund U.S. regulatory and IDE clinical trial activities. We are partnering with Donna Ford-Serbu, CEO of Eximis Surgical, to hire our Head of Regulatory.

Technology Video: Specimen Segmentation and Removal 

This position will be the first internal full-time regulatory employee responsible for managing all FDA interactions while owning regulatory activities for the IDE and De Novo pathways. Additionally, this position will be the hands-on and strategic leader responsible for internalizing the regulatory and clinical activities while supporting CRO selection and management.

This is a remote-based position which will require monthly travel to the Headquarters in Colorado and reports directly to the CEO.


  • Establish and drive regulatory strategies for device approvals and provide clear internal communication with key milestone goals for execution of that strategy.
  • Maintains compliance with the company quality standards, FDA regulations and guidance, applicable EU Medical Device Directives, applicable ISO standards, and other pertinent country specific medical regulatory requirements.​
  • Serve as the Company’s Management Representative per ISO 13485 and during regulatory audits.
  • Develops communication plans and drives internal preparation for meetings with regulatory authorities to ensure strong relationships with authority contacts.
  • Participates in internal audits, assessments, and Management Reviews of the QMS with suggested changes for continuous improvement.
  • Identifies and oversees qualified internal resources, contractors, and consultants to support timely execution of deliverables.
  • Authors regulatory submissions such as pre-subs, IDE submissions and de novo / 510(k)s in support of gaining market clearance from regulatory bodies.
  • Manages regulatory budget.
  • This is not an exhaustive list of duties or functions

Bachelor’s degree in science related field.

  • Minimum of 7 years management experience in a medical device or related industry.
  • Experience with energy-based medical devices preferred.
  • Expertise developing novel or breakthrough Class II or III medical or surgical devices.
  • Has in depth knowledge of FDA § part 812, 820; ISO 13485, 14155, 14971 and MDD, and MDR regulations.
  • Has excellent attention to detail and documentation practices.
  • Ability to read, analyze, and interpret clinical journals and technical reports.
  • Has a proven regulatory track record in medical device industry.
  • Excellent interpersonal and communication skills.
  • Strong leadership skills.
  • Excellent ability to multi-task and prioritize.
  • Be a self-starter that is comfortable turning high-level direction into a plan that yields results.
  • Demonstrated ability to thrive in a high-paced, rapidly changing environment.
  • A demonstrated Team Player able to work with an experienced Eximis Surgical team with confidence and professionalism.
  • Candidate must have strong desire to be part of a very dynamic and mission driven company.
  • Ability to work flexible hours.
  • Ability to travel up to 10% Domestic or International.


Eximis Surgical Inc., develops innovative technologies for the removal of large specimens during minimally invasive procedures. The company is in the pre-market phase and is actively working towards FDA submission for its first device in the platform. Eximis Surgical’ proprietary technology is designed to provide surgeons a fully automated and contained system that leverages controlled RF energy delivery to segment large tissue specimens for removal through a small incision.

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Company Overview


Donna Ford-Serbu

Co-Founder & CEO

Bob Luzzi



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EIN Presswire - Eximis Surgical Secures $8.7 Million in Financing

Eximis Surgical Secures $8.7 Million in Financing


Electrical Engineer

Remote (US)


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