Vivalyx GmbH: Regulatory Affairs & QM Manager (m/f/d)

Vivalyx GmbH is looking for a Regulatory Affairs & QM Manager (m/f/d)

We, Vivalyx, are a medical technology startup from Aachen dedicated to saving people suffering from organ failure. Our goal is to significantly increase the vitality and number of donor organs. The company is currently in the preparation phase for certification and the associated studies. For this purpose, we are looking for new colleagues (m/f/d) starting from 01.03.2024 (or later) for 32-40 hours a week.

We offer the opportunity to work on highly innovative cutting-edge technology with a good purpose in a dynamic, highly qualified, and highly motivated team. In addition, we work very flexibly, mobile, and in flat hierarchies. We also offer further training and career advancement opportunities, as well as an attractive employee participation program.

Tasks

As a RA and QM Manager, you will accompany the development of our technology and be the point of contact for regulatory issues within the team and for our external partners. You will be responsible for developing and implementing strategies to comply with regulatory requirements. You will compile technical documentation and control necessary design changes.

You will ensure compliance with our quality management according to ISO 13485 and 21 CFR 820 and develop it further with us. You will be able to contribute to all typical QM areas and keep an overview of audits, data analysis, corrective and preventive measures, customer feedback, supplier evaluation, complaints, training, and validations. You will negotiate quality agreements with our suppliers and conduct supplier audits.

Requirements

• Motivation and enjoyment of work – especially in medical technology and development
• Independence and commitment
• Technical or scientific degree or comparable training
• Sveral years of professional experience in the medical device sector, preferably in RA and/or QM
• Preferably experienced in applying ISO 13485, ISO 14971, 21 CFR 820, and MDR
• Preferably experienced in applying standards for the electrical safety of medical devices, e.g., IEC 60601, IEC 62366
• Confident handling of Microsoft Office and proficient English in spoken and written form
  
  

We look forward to hearing from you.