Medical Device Project B.V. provides QA / RA support to medical device manufacturers for the purpose of registration of their products within and outside of Europe. We are always looking for technical experts who can strengthen our team and help customers to meet the QMS and regulatory requirements for the medical device industry. Knowledge of medical device regulations is a requirement.
The consultant assists the customer in setting up and maintaining technical documentation of medical devices for market approval, within Europe (CE marking) and beyond. In addition, the consultant helps the customer with the design, implementation and maintenance of the quality management system, based on ISO 13485 and regulations. The consultant can also play a role in the development process of medical devices (such as drawing up specifications, reviewing documentation and supervising risk management sessions).
For more details, see our services & expertises.
• Supporting / guiding product development teams;
• Writing / maintaining product dossiers;
• Performing gap analyzes;
• Advising on the market approval strategy;
• Guiding risk management sessions;
• Supporting and / or supervising validation studies;
• Assisting in setting up and implementing product registration processes;
• Set up, implement and maintain quality management systems;
• Performing audits (internal audits, supplier audits);
• Provide training
• Relevant BSc / MSc / PhD education;
• Minimum 5 years of QA / RA work experience in the medical device industry;
• Project management skills;
• Excellent communication and social skills;
• Hands on mentality;
• Excellent command of the Dutch and English language;
• Driver’s license
• Minimal 0,8 FTE
• Very varied work in a dynamic environment;
• Experienced team with ample opportunities to develop yourself;
• High degree of independence and responsibility;
• Working alternately on location at the customer or from home;
• Competitive salary;
• Good secondary employment conditions, including a company car.
Do you have further questions? Then please contact Jeannette van Loon: 06 - 1103 91 00.
Are you interested? Send your response to email@example.com