Beschrijving

For one of my clients in de medical devices industry, I’m looking for a talented, enthusiastic QA/RA professional in Eindhoven area. Are you passionate about making a difference in the medical device industry? Join a dynamic team focused on innovative healthcare solutions and contribute to ensuring quality and compliance within a growing startup.

Tasks & responsibilities

• Collaborate with Design & Development teams to ensure compliance with regulatory standards for new and modified devices
• Detail-oriented review and documentation of technical information
• Manage technical documentation in accordance with relevant legislation and oversee the preparation, review, and submission of regulatory documents
• Implement, monitor, and optimize quality processes
• Administer regulatory dossiers to support product licensing applications and maintenance for regulatory authorities
• Participate in and support external quality audits, conducting internal audits when necessary
• Stay updated on the latest developments in regulations and quality standards in the medical devices industry.

Profile

• HBO+ or equivalent mindset, preferably with a background in Medical Technology
• Minimum 2-4 years of experience in Quality Assurance and Regulatory Affairs in the MedTech industry
• Strong understanding and application of regulatory requirement
• Experience with software in medical devices is a plus
• Analytical with a hands-on approach and excellent communication skills
• Adherence to high-quality standards even under tight deadlines
• Proficiency in English and preferably Dutch
• Knowledge of relevant regulations, such as ISO 13485, MDR &  FDA regulations

Company description  
This medical device company is dedicated to delivering high-quality products and solutions globally. Their commitment to innovation in healthcare drives them to develop cutting-edge software, hardware, and medical devices. Their culture thrives on problem-solving and prioritizes the well-being of patients and healthcare professionals.

Offer

• 40/32 hours a week
• Market competitive salary (depending on knowledge, experience and level of education)
• Excellent additional benefits
• Flexible working hours in a hybrid environment

Act now
Do you have any questions or are you excited about this vacancy? Please contact Marre Raddatz at m.raddatz@morgangreen.nl or +31 (0)30 200 3408!