You will be working in a team that ensures product compliance with relevant standards and Nipro's design and development process. This role is crucial in fostering a culture of design for compliance and quality, supporting continuous improvement, and ensuring the safety and regulatory compliance of our medical devices. You will collaborate with cross-functional teams to support the development of innovative and compliant medical devices that positively impact patient outcomes.
What you’ll do
Design Compliance (40%)
1. Ensure product compliance with applicable standards and regulations.
2. Prepare and maintain technical documentation according to MDR requirements.
Documentation Control (10%)
3. Maintain Design History Files (DHF) and controlled documents.
Collaboration and Co-ordination (20%)
4. Collaborate with cross-functional Nipro teams in EMEA and Japan.
5. Interface with contract developers and manufacturers in Europe and Japan, ensuring consistency and traceability of product DHF and technical documentation
Quality, Regulatory and Risk Management (20%)
6. Internally champion compliant and efficient design control in new product development.
7. Support product risk management, focusing on risk identification and evaluation.
8. Collaborate with Regulatory Affairs to ensure design controls, particularly risk management files, incorporate relevant regulations, standards, and the generally acknowledged state of the art. Ensure registration needs and changes to regulatory requirements are taken into account in the strategic planning and execution of design & development activities to optimize market access.
9. Drive the selection and management of test houses. Support QA in test house qualification
10. Anticipate, prepare for, and support QA in ISO 13485 audits on local QMS for R&D processes.
11. Manage/execute CAPAs assigned to design & development as required.
Continuous Improvement & Training (10%)
12. Help identify opportunities to improve operational effectiveness of R&D SOPs & WIs.
13. Collaborate with HR & QA department to provide mentoring and training on Quality Systems & Compliance, maintaining training records.
What you’ll need
14. University degree in Engineering, Quality Management, or related field.
15. Team player mindset, coaching and supporting the team in best practices to achieve compliance.
16. Experience in developing complex medical devices (class 2B/Class 3) with embedded software.
17. Experience in communication with notified bodies
18. Familiarity with quality techniques and statistical methods (e.g Six Sigma)
19. Experience with haemodialysis equipment and related technical standards (IEC 60601-2-16, ISO 23500, ISO 10993) is a strong plus.
20. Familiarity with applicable Medical Device Cybersecurity regulations & standards is a plus
21. Expertise in design control, design change management, risk management, and product compliance.
22. Maintain the Applied Standards List for haemodialysis machines, triggering possible Risk Management review in case of a detected change in the state of the art
23. Strong understanding of MDR requirements and IEC 60601-1 standards.
24. Familiarity with quality techniques and statistical methods.
25. Strong familiarity with ISO 13485, ISO 14971, IEC 62304 and IEC 62366 is an asset
26. Collaborate with cross-functional Nipro teams in EMEA and Japan, including R&D, Technical Service, QA, RA, Clinical and Marketing
27. Being able to speak Japanese is also a strong asset but not mandatory
Why you should apply
You will be part of a dynamic team that values innovation and compliance, working on projects that make a real difference in patient outcomes.
Our collaborative environment and commitment to continuous improvement provide excellent opportunities for professional growth.
You will have the possibility to work in an environment where you can build up and leave a legacy. Your impact will be big.