Clinical Evaluation Specialist
Solliciteren
Plaats
Mechelen2800
Antwerpen
België
Contract
Vooltijds, Onbepaalde duurDatum gepubliceerd
2026-02-25Online to:
2026-04-26EUR 15.00 HOUR
Clinical Evaluation Specialist
- NIPRO Corporation - Global
- Antwerpen
- 15 uren geleden
About The Company
As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 38,000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical EMEA, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.
For Nipro Medical, we are looking for a Clinical Evaluation Specialist who is experienced, hands-on, and communicative to join us in our Regulatory, Quality and Clinical team, based in our EMEA headquarters office in Mechelen, Belgium.
About The Role
How you will contribute
Clinical Evaluation (35%)
Develop clinical evaluation plans and reports supporting regulatory approval and patient safety
Conduct systematic literature reviews to support clinical evidence and post‑market activities
Post Market Clinical Follow Up and Post Market Surveillance Activities (45%)
Lead post‑market surveillance and clinical follow‑up planning, execution, and reporting
Analyze safety and performance data to identify risks and improvement opportunities
Training (10%)
Translate clinical insights into actions for product development and organizational learning
Clinical Study Activities (10%)
Organize and manage post‑market clinical studies with internal and external partners
What You Bring To Nipro
University degree in life sciences, medicine, biomedical engineering, or related field
Proven experience authoring clinical evaluation documentation for medical devices: Clinical Evaluation Plan (CEP's) and Clinical Evaluation Reports (CER's)
Strong knowledge of European medical device regulatory requirements: MDR 2017/745 and MEDDEV 2.7.1 guidelines
Experience with post‑market surveillance, safety data analysis, and clinical follow‑up
Excellent analytical, writing, and stakeholder communication skills
Why you should apply
You will work in a highly collaborative European team with strong clinical expertise
You will have real impact on patient safety and medical device performance
You will influence product development through meaningful clinical insights
You will gain exposure to diverse products and international stakeholders
You will join a company that values quality, learning, and continuous improvement
You will be working in a multicultural environment with more than 30 nationalities
NIPRO delivers on its purpose to help all people Live Longer. Live Better.
Our purpose is grounded in care, respect, and a deep commitment to the well-being of every life we touch—patients, partners, and team members. We believe that every colleague at NIPRO plays a vital role in our mission: to push innovation forward, improve patient outcomes, and make world-class healthcare accessible to all.
Respect is active and essential at NIPRO - it is our way of working, thinking, and growing together. We promote an environment where people feel safe to contribute, constructive ideas flow freely, and every person is treated with dignity.
As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 38,000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical EMEA, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.
For Nipro Medical, we are looking for a Clinical Evaluation Specialist who is experienced, hands-on, and communicative to join us in our Regulatory, Quality and Clinical team, based in our EMEA headquarters office in Mechelen, Belgium.
About The Role
How you will contribute
Clinical Evaluation (35%)
Develop clinical evaluation plans and reports supporting regulatory approval and patient safety
Conduct systematic literature reviews to support clinical evidence and post‑market activities
Post Market Clinical Follow Up and Post Market Surveillance Activities (45%)
Lead post‑market surveillance and clinical follow‑up planning, execution, and reporting
Analyze safety and performance data to identify risks and improvement opportunities
Training (10%)
Translate clinical insights into actions for product development and organizational learning
Clinical Study Activities (10%)
Organize and manage post‑market clinical studies with internal and external partners
What You Bring To Nipro
University degree in life sciences, medicine, biomedical engineering, or related field
Proven experience authoring clinical evaluation documentation for medical devices: Clinical Evaluation Plan (CEP's) and Clinical Evaluation Reports (CER's)
Strong knowledge of European medical device regulatory requirements: MDR 2017/745 and MEDDEV 2.7.1 guidelines
Experience with post‑market surveillance, safety data analysis, and clinical follow‑up
Excellent analytical, writing, and stakeholder communication skills
Why you should apply
You will work in a highly collaborative European team with strong clinical expertise
You will have real impact on patient safety and medical device performance
You will influence product development through meaningful clinical insights
You will gain exposure to diverse products and international stakeholders
You will join a company that values quality, learning, and continuous improvement
You will be working in a multicultural environment with more than 30 nationalities
NIPRO delivers on its purpose to help all people Live Longer. Live Better.
Our purpose is grounded in care, respect, and a deep commitment to the well-being of every life we touch—patients, partners, and team members. We believe that every colleague at NIPRO plays a vital role in our mission: to push innovation forward, improve patient outcomes, and make world-class healthcare accessible to all.
Respect is active and essential at NIPRO - it is our way of working, thinking, and growing together. We promote an environment where people feel safe to contribute, constructive ideas flow freely, and every person is treated with dignity.
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