Quality Manager & Regulatory Affairs Manager medical AI software (m/f/d) full-time/part-time

ABOUT US

Alzheimer's and other forms of dementia are the second most feared diseases after cancer. Our medical AI software enables early detection of these diseases. The earlier these and other neurodegenerative diseases are detected, the greater the chance of successful treatment.

Do you want to join us in taking this innovative software solution to the next level?

THESE TASKS AWAIT YOU

• Updating and maintaining the technical documentation of our medical devices and the associated QM system
• Shared responsibility for compliance and implementation of applicable regulatory requirements (ISO 13485, MDR, FDA)
• Preparation of market specific regulatory documentation
• Monitoring and analysis of norms, standards and regulatory requirements
• Liaison for regulatory issues from development
• Post market surveillance and vigilance
• Correspondence with regulatory authorities and registrars
• Support in the preparation, organization and monitoring of audits by notified bodies and national and international authorities

WHAT YOU BRING WITH YOU

• Successfully completed studies (medical technology, biotechnology, biology or comparable scientific studies) or comparable professional qualification
• Ideally, first professional experience in quality management and regulatory affairs in a medical device company - but once is always the first time.
• Experience with international regulatory affairs is an advantage
• Good knowledge of written and spoken English
• Strong sense of responsibility as well as a structured and analytical working style
• Willingness to work cross-functionally

You are missing some of the mentioned requirements, but you really want to be part of AIRAmed? We look forward to getting to know you anyway!

WE OFFER

• A highly motivated and collegial environment where you can contribute your ideas and make a difference from day one
• Short decision paths and flat hierarchies
• A high level of personal responsibility
• Flexible working hours

WHY WE DO WHAT WE DO

Innovative research results often disappear in a drawer and never reach the patient. This is exactly what we want to prevent at AIRAmed.
We develop medical software solutions with the goal of bringing them to patients in a timely manner. Software solutions that have a significant impact on the live of patients and their families and improve the chances of successful therapies.

How do we achieve this?
With a passion for innovative technology and a unique team that enjoys its work and doesn't shy away from challenges.

DOES ALL THIS SOUND EXCITING TO YOU?

Then we look forward to receiving your application:

apply@airamed.de

apply@airamed.de