Register for Postdocs & Researchers - AI Medical Technology - Internship Project VT24

AI Medical Technology

ARTIFICIAL INTELLIGENT IMAGE ANALYSIS IN HEALTHCARE

Target group
Postdocs and researchers

About the company
AI Medical Technology has developed the smartphone application Dermalyser. Dermalyser is a
clinically validated smartphone application powered by artificial intelligence (AI) providing diagnostic decision support for medical professionals in clinical settings. Dermalyser enables fast and accurate diagnosis of melanoma, the most dangerous type of skin cancer. The medical professional takes an image of the patient’s suspicious skin lesion and, within a few seconds, receives a result from the AI.
With Dermalyser, skin cancer can be diagnosed in time, and unnecessary surgeries can be avoided. Dermalyser can save patient lives while the standardised course of care for melanoma and healthcare becomes time and cost-efficient.

The project
As a Junior Quality Assurance/Regulatory Affairs Professional at AI Medical Technology, you will
support the QA/RA department in ensuring compliance with regulatory requirements applicable to our medical device. Working closely with cross-functional teams, you will be involved in various aspects of quality assurance and regulatory affairs processes. Key responsibilities include:

• Assisting in maintaining quality management systems (QMS) in accordance with applicable
  regulatory standards ISO 13485 and the EU Medical Device Regulation 2017/745.
•  Supporting the maintenance of regulatory compliance documentation, including technical
  files.
• Participating in internal and external audits to assess compliance with quality standards and
  regulations.
• Conducting product quality investigations, root cause analyses and implementation of
  corrective/preventive actions (CAPAs) as needed.
• Assisting in reviewing and approving product documentation and promotional materials to
  ensure compliance with regulatory requirements.
• Collaboration with R&D and other departments to ensure quality and regulatory
  considerations are addressed throughout the product lifecycle.
•  Staying up to date with regulatory requirements and industry trends to provide
  recommendations for continuous improvement.
  
  
  The candidate
  We are looking for a candidate with the following background and skills:
  
  
• Master’s degree in a relevant field (e.g., Biology, Chemistry, Engineering) or equivalent
  experience.
• Prior internship or work experience in quality assurance, regulatory affairs, or a related field
  preferred.
• Knowledge of quality management systems (QMS) and regulatory requirements (e.g., FDA
  regulations, ISO standards).
• Strong analytical skills with the ability to troubleshoot and solve problems effectively
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Detail-oriented with a commitment to maintaining accuracy and compliance in all tasks.
• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

Contact information
Name: Christoffer Ekström
Email: christoffer@aimedtech.com
Telephone: +46704027101
Company: website: www.aimedtech.com
Office: Universitetsvägen 8, Stockholm County 114 18, SE