Director of QA & RA

Aidoc is recruiting a Director of QA & RA in Tel Aviv. Join our team!

About Aidoc:

Aidoc is a pioneering force in clinical AI. Our clinical AI imaging solutions help physicians quickly identify and diagnose urgent cases and improve patient outcomes. Built on Aidoc’s exclusive aiOS, we analyze and aggregate medical data to enable care teams to operationalize the unexpected and work seamlessly with a continued focus on the patient. Aidoc AI is always on, running in the background to change the foreground.

We have 17 FDA clearances, and our solutions are used in more than 1,000 hospitals, including leading health systems in the US. Funded by some of the industry’s leading VC’s, Aidoc has raised more than $250 million to date, and was chosen as one of TIME’s 50 most genius companies.

About this role:

The RA team in AIdoc is unique in the extensive scope of medical devices it manages, and its pioneering position in the realm of AI regulation.

The team is responsible for receiving FDA, CE and other regulatory marking authorizations. ensuring conformity with all required medical device regulations and standards, maintaining Aidoc’s QMS, and assuring compliance with privacy requirements.

The Director of QA & RA is a pivotal link between the medical device regulators requirements to all company departments, promising Aidoc’s quality management system, regulatory submissions, clinical work, product verification and validation processes meet the highest regulatory standards.

Responsibilities:

• Manage implementation of international standards and regulatory requirements into company products, product-related processes, and QMS.
• Regulatory submissions, including CE, FDA and additional regulatory authorities as needed.
• Responsible for internal and external regulatory audits.
• Provide regulatory input into the selection of strategic product development targets for the company.
• Responsible for Risk Management process implementation.
• Ensuring Aidoc maintains adequate processes for developing, validating and documenting production processes.
• Responsible for the establishment of product acceptance criteria and product V&V.
• Providing training and/or taking other actions to satisfy competency requirements.
• May act as, or supervise, the PRRC (MDR 2017/745, article 15) and Management Representative (ISO 13485:2016, 5.5.2, 21 CFR 820
• 820.20(b)(3))
  
  

• Great interpersonal skills and a strong passion for regulation, quality, compliance, and the healthcare innovation world.
• At least four years of professional experience in leading regulatory affairs or in QMS management related to medical devices, including leading a QA and /or RA team
• Experience in regulatory submissions to FDA and CE, including experience in regulatory litigation.
• Experience in successfully leading FDA and CE inspections
• Bachelor’s Degree in Engineering, Life/Exact Sciences, or Law.
• Experience in AI compliance - a strong advantage
• Experience in clinical-regulatory work - a strong advantage
• Managerial experience in leading a department.
• Privacy compliance experience - an advantage
• Corporate compliance experience - an advantage
• Start-up managerial experience - an advantage
  
  

• Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients’ lives)
• Office close to HaShalom train station with free parking
• Stocked up kitchen & meal card
• Breakfast and lunch made by our personal chef
• Wellness- yoga, pilates, and functional workouts in the office
• Amazing culture - collaborative, transparent & fun!
• Attractive compensation package & benefits