Compliance Specialist

Why you should join our team

Aidoc is the leading provider of enterprise A.I. solutions for medical imaging. We are already deployed in hundreds of medical centers around the globe, some of which are the leading in the world. Our products use cutting-edge A.I. to detect and highlight critical medical conditions, thus enabling providers to focus their time and attention where it really matters. Aidoc products have received 7 FDA and CE clearances, and we are working on developing many more products and their respective regulatory approvals.

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.

This position is a key role in Aidoc’s Regulations and QA 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.

About this role

  • 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)
  • Confirm and sustain an effective Quality Assurance Systems is in place to ensure that local operations are robust, sustainable, effective and fully compliant with regulatory requirements and policies
  • Manage the quality processes – implementing requirements within the company in all departments in the most effective and efficient manner – implementing processes and methods supporting fast and changing business strategy and needs, while maintaining the highest quality standards
  • Manage sustainable and effective CAPA and Complaint processes.
  • Support and prepare the company for internal and external audits.
  • Work closely with R&D and SW QA teams to support the “startup-minded” SW development process – agile, compliant, fast, and efficient.
  • Continuously improve the QMS and regulatory-related processes.

We are looking for

  • Bs.C Pharma, Bachelor’s Degree in Engineering, Life Science/Exact Science/law.
  • Experience in the medical device industry and demonstrated experience in QMS compliance – a strong advantage
  • Outstanding experience working to optimize processes and workflows
  • Professional written and verbal communication skills.
  • Able to deliver positive and proactive communications and foster excellent working relationships with stakeholders at any level of the organization
  • Analytical mind, good attention to detail and problem solving skills within a structured process
  • Structured thinking and capability to drive a multidisciplinary project to completion
  • A true team player with a passion for working with people.
  • Proactive and accountable attitude.
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