Consultant Medical Devices Quality & Regulatory Affairs

We have an exciting opportunity to join our team as Consultant Medical Devices Quality & Regulatory Affairs. In this role, you will serve a wide variety of clients in the medical device industry. With your medical devices regulatory knowledge, you are responsible for supporting Qserve clients to facilitate their business goals, assuring regulatory compliance and getting market access for a wide range of medical devices. You will be part of our international team of medical device experts, working from across the world.

What You’ll Bring To The Team

The candidate we are looking for is a passionate regulatory professional, who has experience in writing and reviewing medical devices technical documentation. With your understanding of the design and development process (specifications, verification, and validation) and risk analysis, you are able to engage a large variety of medical device technologies and guide clients to successful global compliance.

Your profile :

• Technical or scientific degree (BSc, MSc, or Ph.D.) in biomedical engineering, physics, (medical) biology, or similar;
• At least a few years of working experience in the field of medical devices (EU-MDD and EU-MDR) by fulfilling positions in the medical devices industry, another consultancy, or at a Notified Body, in either quality, regulatory or clinical roles;
• Knowledge and / or understanding of quality assurance and regulatory affairs in the MedTech industry or Notified Body environment;
• Knowledge of EU and US Medical Device Regulations;
• Experience with writing technical documentation and regulatory documents;
• Familiar with medical devices risk management;
• Pragmatic, communicative, service-oriented and strong organizational skills;
• Practical experience project management experience;
• Fluent German and English;
• Drivers license.

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