Project Manager – Regulatory Affairs

Why you should join our team

Working in Aidoc’s Regulatory and Compliance Department means working on innovative aspects of A.I., helping shape the future of healthcare.
Since regulation is an absolute and foremost key for market entry, Aidoc’s Compliance Department is extremely
strategic – working externally with the most challenging regulators on (namely the FDA) and working internally with all company departments, on different product aspects –  from the design phase and until the device is fully integrated into the market. 

Working in Aidoc’s Regulatory and Compliance Department means working on innovative aspects of A.I., helping shape the future of healthcare. Since regulation is an absolute and foremost key for market entry, Aidoc’s Compliance Department is extremely strategic – working externally with the most challenging regulators on (namely the FDA) and working internally with all company departments, on different product aspects –  from the design phase and until the device is fully integrated into the market. 

About this role

  • You will have full ownership of products regulatory path: lead and manage the regulatory process of Aidoc’s products from an initial idea until submission and clearance for use.
  • Internal project management: lead and manage all steps required for regulatory submissions, defining work plans and timelines, making sure all company stakeholders understand what is required from them, and deliver excellent outputs on time.
  • Learn and understand all aspects of regulatory and product requirements and outputs: clinical need, product specifications, software design, development and validations, clinical studies and validation, labeling requirements.
  • Coordinating and taking part in FDA pre submissions and consulting with industry-leading advisors.
  • Generate creative processes for improving future submission processes.
  • Perform high-level regulatory and market research and analysis, understanding requirements and competitor’s strategies.
  • Own regulatory and compliance requirements within the company, creating lean and effective processes within different company departments promising practical “in compliance” work methods.
  • You will have full ownership of products regulatory path: lead and manage the regulatory process of Aidoc’s products from an initial idea until submission and clearance for use.
  • Internal project management: lead and manage all steps required for regulatory submissions, defining work plans and timelines, making sure all company stakeholders understand what is required from them, and deliver excellent outputs on time.
  • Learn and understand all aspects of regulatory and product requirements and outputs: clinical need, product specifications, software design, development and validations, clinical studies and validation, labeling requirements.
  • Coordinating and taking part in FDA pre submissions and consulting with industry-leading advisors.
  • Generate creative processes for improving future submission processes.
  • Perform high-level regulatory and market research and analysis, understanding requirements and competitor’s strategies.
  • Own regulatory and compliance requirements within the company, creating lean and effective processes within different company departments promising practical “in compliance” work methods.

We are looking for

  • Bachelor’s Degree in Engineering, Life Science/Exact Sciences, or Law.
  • Demonstrated experience in excellent project and program management – a must!
  • Experience working to optimize processes and workflows – an advantage.
  • Structured thinking and capability to drive a multidisciplinary project to completion
  • Excellent communication skills, both written and verbal. A true team player with a passion for working with people.
  • Proactive and accountable attitude.
  • Care for details and accuracy
  • Growth mindset – willingness to learn and improve both self and environment, in diverse fields
  • Bachelor’s Degree in Engineering, Life Science/Exact Sciences, or Law.
  • Demonstrated experience in excellent project and program management – a must!
  • Experience working to optimize processes and workflows – an advantage.
  • Structured thinking and capability to drive a multidisciplinary project to completion
  • Excellent communication skills, both written and verbal. A true team player with a passion for working with people.
  • Proactive and accountable attitude.
  • Care for details and accuracy
  • Growth mindset – willingness to learn and improve both self and environment, in diverse fields
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