Position: R&D engineer

Location: Kfar Neter, Netanyia, Israel

We are seeking for VP Regulatory Affairs
Sensible Medical Innovations has set out to develop a new standard of care in lung fluid management. Sensible developed the ReDS™ medical technology that stems from defense “see-through wall” application. The technology is well-positioned to be a game-changer in a wide range of applications and become the next generation monitoring and imaging modality.
Seeking candidate with a proven track record of successful submissions and the ability to define and execute a comprehensive regulatory strategy. Reports to the company CEO.

Responsibilities

• Establishing a dialog with the regulatory authorities (e.g. FDA, Notified body) to discuss the regulatory plan and assure an efficient and productive process.
• Strategy planning for new products/new models (clarifying classifications, relevant global regulations and following implications to the business).
• Working with R&D to assure adherence to the agreed-upon regulatory path, and to resolve emerging conflicts with regulatory requirements
• Projecting regulatory requirements,
• Assuring implementation and long term compliance with the requirements,
• Assuring Risk management along with the product full lifecycle,
• Assuring the alignment b/w V&V planning and regulatory requirements, as well as the quality of execution.
• Assuring the conductance of clinical evaluation
• Providing regulatory inputs to the manufacturing process
• Leading the regulatory aspects of labeling and marketing materials
• Concluding the above into inclusive submissions, and defend the submissions externally.
• Leading regulatory aspects of product changes along the product lifecycle
• Leading the regulatory aspects of post-marketing activities (e.g. vigilance reporting)
• Carrying management responsibilities as appropriate.

Education/Skills and Experience Requirements

• MS/Ph.D. in Life/Health Sciences/Biomedical Engineering.
• Holding the Regulatory Affairs Certification (RAC). – Advantage
• A proven leader with a minimum of 10+ years’ experience in the biomedical industry.
• Must have experience with global regulatory agencies and ability to advise on regulatory strategy in the US and Europe.
• Experience from a company that sells – Advantage
• Able to drive strategic thinking and plans for successful regulatory outcomes.
• Excellent Professional writing skills.
• Experience in interfacing with regulatory authorities, including a successful track record of submissions of class II devices in the EU and in the USA
• Strong planning, organizational and leadership skills.
• Dynamic individual with strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment.
• Results-oriented. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
• Detail-oriented

CV please send to neta.d@sensible-medical.com