Job opening with Xact Medical
Dayton medical device startup Xact Medical is searching for a new team member to fill a lead role in quality systems and regulatory compliance. See full details below.
Xact Medical is an institutional investor-backed medical device startup located in Springboro, Ohio. With technology exclusively licensed from Cincinnati Children’s Hospital and Ben Gurion University, Xact is developing a pioneering product in the field of point of care robotics – the Fast Intelligent Needle Delivery System, or FIND.
FIND is a hand-held medical robot that integrates ultrasound imaging with robotics to turn every clinician into an expert at precision needle placement, which will improve patient outcomes and save hospitals time and money. The initial target market is central vascular access, to be followed by regional anesthesiology and biopsy.
With extensive market research completed to confirm product-market fit and an advanced prototype being tested and refined to final design, Xact is currently seeking the right individual to lead our quality systems and regulatory compliance and to grow with us as we go to market. Interested parties should contact Andrew Cothrel, CEO, at firstname.lastname@example.org for more information.
This role’s responsibilities (Director or Manager level depending on experience) include creating and enhancing quality management systems and supporting documentation in compliance with FDA QSRs and ISO 13485, training the Xact team in good QMS practices, and ensuring compliance with all applicable regulatory standards. These activities fall into three groups of responsibility:
Product development/design control
Xact has a QMS in place that is appropriate for its current stage (development), and is following QSR-compliant design controls. Next steps are to get procedures revised and get additional procedures in place, as well as enhancements and ongoing maintenance to the design history file. Once that groundwork is laid, intensive work in verification and validation will be needed. Prior experience in creating standard operating procedures, work instructions, test cases and protocols, validation documents, etc. for an FDA regulated medical products company (device, Dx, or Rx) is essential (and ideally, at least some of this work experience was on a Class II electromechanical medical device, but that is not essential). After V&V is complete, this role will lead efforts to create, submit, and defend a 510(k) submission. Prior experience with 510(k) submissions is highly desirable. We can supplement your efforts with outside experts, but we need to own the 510(k) submission.
Commercial & Manufacturing Operations
Some prior experience with as many of these as possible is desired: CAPA, complaint handling, recalls, material review & disposition, supplier qualification, supplier controls, QC. These activities don’t really ramp up until 2020, so we will have the opportunity to shore up any gaps by that time.
Ongoing QMS continuous improvement
Experience conducting audits and management reviews, as well as creating and delivering employee training, are a plus.