We are looking for a Senior R&D Compliance
Engineer who is passionate, detail-oriented, and collaborative to
join us in our R&D Engineering team, based in our Mechelen
office in Belgium or in our office in Malmö, Sweden. About the role
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%) - Ensure
product compliance with applicable standards and regulations. -
Prepare and maintain technical documentation according to MDR
requirements. Documentation Control (10%) - Maintain Design History
Files (DHF) and controlled documents. Collaboration and
Co-ordination (20%) - Collaborate with cross-functional Nipro teams
in EMEA and Japan. - 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%) - Internally champion
compliant and efficient design control in new product development.
- Support product risk management, focusing on risk identification
and evaluation. - 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. - Drive the selection and management of
test houses. Support QA in test house qualification - Anticipate,
prepare for, and support QA in ISO 13485 audits on local QMS for
R&D processes. - Manage/execute CAPAs assigned to design &
development as required. Continuous Improvement & Training
(10%) - Help identify opportunities to improve operational
effectiveness of R&D SOPs & WIs. - Collaborate with HR
& QA department to provide mentoring and training on Quality
Systems & Compliance, maintaining training records. What you'll
need - University degree in Engineering, Quality Management, or
related field. - Team player mindset, coaching and supporting the
team in best practices to achieve compliance. - Experience in
developing complex medical devices (class 2B/Class 3) with embedded
software. - Experience in communication with notified bodies -
Familiarity with quality techniques and statistical methods (e.g
Six Sigma) - Experience with haemodialysis equipment and related
technical standards (IEC 60601-2-16, ISO 23500, ISO 10993) is a
strong plus. - Familiarity with applicable Medical Device
Cybersecurity regulations & standards is a plus - Expertise in
design control, design change management, risk management, and
product compliance. - 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 - Strong
understanding of MDR requirements and IEC 60601-1 standards. -
Familiarity with quality techniques and statistical methods. -
Strong familiarity with ISO 13485, ISO 14971, IEC 62304 and IEC
62366 is an asset - Collaborate with cross-functional Nipro teams
in EMEA and Japan, including R&D, Technical Service, QA, RA,
Clinical and Marketing - 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. About the company Nipro Europe Group Companies is part
of Nipro Corporation Japan, a leading global healthcare company
with over 38.000 employees worldwide. Its European headquarters in
Mechelen is home to Nipro Medical EMEA, Nipro PharmaPackaging
International, and the Institute for Medical Practice (iMEP)
Belgium - a fully equipped research and training facility for
medical professionals and Nipro employees alike. The geographical
scope includes Europe, Africa, the Americas, and India. Join us to
contribute to the development of cutting-edge medical devices and
be a key player in ensuring their safety and regulatory
compliance.