Compliance and Processes Director

Why you should join our team

 

The compliance team in Aidoc is responsible for regulation, quality, privacy, and Security.
Since compliance is a key for market entry in the medical device world, Aidoc’s Compliance Department is extremely strategic – working externally with the most challenging regulators on innovative aspects of AI and medical devices (namely the FDA) and working internally with all company departments, on different company aspects – from the design phase and until a product is fully integrated into the market.

 

The compliance team in Aidoc is responsible for regulation, quality, privacy, and Security. Since compliance is a key for market entry in the medical device world, Aidoc’s Compliance Department is extremely strategic – working externally with the most challenging regulators on innovative aspects of AI and medical devices (namely the FDA) and working internally with all company departments, on different company aspects – from the design phase and until a product is fully integrated into the market.

About this role

This position is a key role in Aidoc’s Regulations and Compliance Department, and you will be a pivotal link between the regulator’s requirements to ALL company departments, promising Aidoc’s quality management system meets the highest compliance and industry standards.

  • You will be responsible to fully understand regulatory and quality requirements, and best industry standards, including medical device QMS (ISO 13485, FDA QSR, MDSAP), Software Development Life Cycle (SDLC), and Risk Management (RA).
  • Build a sustainable and effective QMS: Generate creative processes – implementing requirements within the company with all departments in the most effective and efficient manner – creating processes and methods supporting fast and changing business strategy and needs, while maintaining the highest quality standards.
  • Work closely with R&D and SW QA teams to establish a “startup-minded” SW development process – agile, compliant, fast, and efficient.
  • Explore external and/or internally developed software tools to improve QMS and regulation-related processes.
  • Build sustainable and effective CAPA and Complaint processes.
  • Own compliance requirements, prepare and present compliance of QMS for management review, and manage internal and external audits.
This position is a key role in Aidoc’s Regulations and Compliance Department, and you will be a pivotal link between the regulator’s requirements to ALL company departments, promising Aidoc’s quality management system meets the highest compliance and industry standards.
  • You will be responsible to fully understand regulatory and quality requirements, and best industry standards, including medical device QMS (ISO 13485, FDA QSR, MDSAP), Software Development Life Cycle (SDLC), and Risk Management (RA).
  • Build a sustainable and effective QMS: Generate creative processes – implementing requirements within the company with all departments in the most effective and efficient manner – creating processes and methods supporting fast and changing business strategy and needs, while maintaining the highest quality standards.
  • Work closely with R&D and SW QA teams to establish a “startup-minded” SW development process – agile, compliant, fast, and efficient.
  • Explore external and/or internally developed software tools to improve QMS and regulation-related processes.
  • Build sustainable and effective CAPA and Complaint processes.
  • Own compliance requirements, prepare and present compliance of QMS for management review, and manage internal and external audits.

We are looking for

  • Bachelor’s Degree in Engineering, Life Science/Exact Sciences, or Law.
  • Experience in the medical device industry and QMS compliance – an advantage
  • Demonstrated experience in excellent project and program management
  • Outstanding experience working to optimize processes and workflows
  • 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.
  • Experience in the medical device industry and QMS compliance – an advantage
  • Demonstrated experience in excellent project and program management
  • Outstanding experience working to optimize processes and workflows
  • 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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