CorFlow Therapeutics is seeking highly skilled and experienced medical device professionals. The CorFlow work environment is focussed on quality and to deliver on demanding objectives. The right candidates are communicative, open and thoughtful on their own role in a dynamic team.
Brief description of company
CorFlow Therapeutics was founded in 2016 by renowned interventional cardiologists and medical device entrepreneurs with a life-long dedication to medical device innovation in interventional cardiology. Our Client is incorporated in Baar, Switzerland, and is developing proprietary technologies for diagnosis and treatment of microvascular obstruction (MVO). The technologies will enable interventional cardiologists to diagnose and treat severe heart attack patients with MVO thereby potentially reducing the short- and long-term complication rates in these patients. The company has developed the 1st generation CorFlow Controlled Flow Infusion (CoFI™) console and catheter and is preparing to enter into the First-in-Man multi-center European clinical trial, called the MOCA I trial, to investigate these devices.
CorFlow has a strong management, R&D and clinical team located in Baar, Switzerland. The company has established a world-wide recognized Scientific Advisory Board and enjoys support from Key Opinion Leaders in interventional cardiology in Europe, the United States and Japan. They raised substantial seed financing over the last three years, secured the largest Innosuisse grant ever approved in Switzerland and is preparing to raise additional financing in 2019.
CorFlow Therapeutics AG is currently seeking an experienced Vice President of Regulatory Affairs and Quality Assurance (RAQA) for its regulatory and quality activities in Baar (ZG), Switzerland. The position will be responsible for all regulatory affairs and quality assurance activities related to CorFlow’s Class III CoFI™ System intended to diagnose and treat MVO in patients who have suffered a severe heart attack (STEMI). The CorFlow CoFI™ System is a Class III medical device with a mode of action achieved through a combination of device function and intracoronary drug infusion into the coronary microcirculation, i.e. the CoFI™ System is a Class III combinational medical device.
The VP RAQA will report to the CEO and is a member of the CorFlow management team. The right candidate should be totally dedicated to developing the CorFlow culture and communication needs. He/she should be able to combine the overall CorFlow business objectives with the current world-wide regulatory and quality requirements.
CorFlow is seeking an experienced and thoughtful VP RAQA who has a documented track-record of obtaining regulatory approvals and maintain quality certifications for Class III medical devices.
The main responsibilities of the VP RAQA are:
- In close cooperation with the R&D and clinical activities in CorFlow, secure CE-mark under the new MDR for the 1st and 2nd generation CoFI™ System
- Build and maintain relationships with the selected Notified Body to secure timely European approval of the CoFI™ System
- Secure the Early Feasibility Study (EFS) approval with the FDA and develop the Pre-Market Approval (PMA) strategy with the FDA
- Define and implement the reimbursement strategy for the CoFI™ System in Europe and the United States
- Continued development and implementation of the CorFlow Quality Assurance system according to European and US standards
- Be part of the selection process of CorFlow’s sub-suppliers and ensure that the sub-suppliers are compliant with CorFlow’s regulatory and quality requirements
- Develop and implement the world-wide regulatory strategy for the CorFlow CoFI™ System and ensure that this strategy is anchored with the selected Notified Body, the FDA and Japanese authorities
- Communicate the overall CorFlow RAQA strategy to stakeholders such as the Board of Directors, investors and corporates
In order to complete these tasks successfully, the VP RAQA should have these skill sets and experiences:
- Experience to interact with the FDA and European Notified Bodies
- A proven track record to secure PMA and CE-mark approvals for a Class III combinational medical device
- Ability to develop and maintain personal relationships with internal and external team members
- Preferably earlier experience from an emerging medical device management team
- Proactive approach to communication to secure the overall outcome of the CorFlow RAQA strategy
- Excellent interpersonal communication skills orally and in writing
- Ability to work under pressure and with a high work load over a prolonged period of time
- More than 10 years’ experience from regulatory approval processes and quality assurance for Class III medical devices – preferably in interventional cardiology
- Solid German and English language skills orally and in writing
- Strong critical thinking and problem-solving ability
- Team player who likes to get things done
- Well organized and attention to detail, ability to absorb new information quickly
- Organized individual who is self-motivated, detail oriented and able to work with little supervision
- Ability to deliver high-quality work products under tight deadlines
- Willingness to learn and to grow with the company
Why to work for CorFlow Therapeutics AG?
Joining a promising emerging medical device company in such an early stage is a fantastic chance! The right person will enjoy the amount of responsibility and the very close and committed working atmosphere with the colleagues and the management team. The right incumbent will be totally dedicated to developing the CorFlow culture and future.
If you are interested in this position, please contact:
BLG Executive Search GmbH
60325 Frankfurt am Main
Tel. 069 380 7876 04
If you have an interest to join CorFlow, please do not hesitate to contact us: