Post Market Surveillance & QMS Specialist

Description

Aidoc is recruiting a Post Market Surveillance and QMS Specialist in Tel Aviv. Join our team!

About Aidoc

Aidoc is revolutionizing clinical decision-making with real-time clinical AI imaging solutions, impacting over 60 million patients annually. Our technology empowers physicians to diagnose urgent cases, ultimately improving patient outcomes.

Powered by our proprietary aiOS, Aidoc assists clinicians by precisely highlighting suspected pathological findings directly on medical images and prioritizing cases. This ensures that urgent patients receive the immediate attention they need.

As a leader in clinical AI, Aidoc has the most FDA-cleared Computer-Aided Detection (CAD) solutions, with adoption in more than 1,600 medical centers worldwide.

Since our founding in 2016, Aidoc has secured over $370 million in funding and was recognized as one of TIME’s 50 most genius companies.

About this role

The Compliance team at Aidoc is responsible for regulation, quality assurance, privacy, and security.

As a Post-Market Surveillance and QMS Specialist, you will lead post-market surveillance activities, including collaborating with stakeholders across Aidoc and preparing periodic reports as required by regulations. As a QMS specialist, you will serve as a key link between regulatory requirements and internal teams across the company. Your mission will be to ensure that Aidoc’s quality management system (QMS), regulatory submissions, and product compliance meet the highest industry standards.

In this role, you will act as a subject matter expert in post-market surveillance, including leading complaint investigations, reporting to regulatory authorities, and preparing required surveillance reports. You will also provide expertise in medical device quality requirements and lead critical activities that support our fast-growing business strategy.

Responsibilities

• Post-Market Leadership: Lead Post Market Surveillance (PMS) activities, collaborating with different stakeholders in Aidoc to produce periodical reports as required by regulation.
• QMS Management: Sustain and ensure an effective Quality Management System is in place, confirming that internal operations are robust, sustainable, and fully compliant with regulatory policies.
• Regulatory Implementation: Implement regulatory requirements across various company departments in an effective and efficient manner.
• Subject Matter Expertise: Serve as a subject matter expert on quality requirements and industry best practices, including ISO 13485, FDA/QMSR, ROW regulations, and MDSAP.
• Quality Improvement: Initiate and manage quality improvement activities, such as CAPA (Corrective and Preventive Actions) and quality plans.
• Lifecycle & Risk: Provide expertise on software development lifecycle (SDLC) and risk management.
• Audit & Evaluation: Support and prepare the company for internal and external audits, and conduct supplier evaluations and reevaluations.

Requirements

• Industry Experience: Professional experience in the medical device industry.
• Specialized Knowledge: Experience in Pharmacovigilance and post-market surveillance, including reporting to regulatory authorities.
• Process Optimization: Experience working to optimize processes and workflows.
• Academic Background: Bachelor’s Degree in Engineering, Life/Exact Sciences, or Law.
• Operational Excellence: Ability to support fast and changing business strategy and needs while maintaining high quality standards.

Working at Aidoc

• Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients’ lives)
• We work in a hybrid model, with our new offices located at 34 HaMasger Street in Tel Aviv and parking for employees.
• Amazing and healthy breakfasts and lunches prepared daily by our personal chef!
• Stocked up kitchen & meal card
• Wellness: Aidoc employees-only gym, plus Pilates, Yoga, and functional workouts classes.
• Amazing culture - collaborative, transparent & fun!
• Attractive compensation package & benefits