Senior Clinical Affairs Specialist - Dialyse Machines

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 EMEA, we are looking for a Senior Clinical Affairs Specialist - Dialyse machines to reinforce our clinical affairs team

About the role:

You will be working in a team that develops clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4 and MDR regulations (MDCG 2020-6). Your work will support CE Mark applications, recertifications, and proposed indication/labeling changes, ensuring EU product conformance. You will also develop and review Post Market Clinical Follow-up (PMCF) strategies, participate in Risk Management assessments, and Post Market Surveillance (PMS).

What you’ll do:

Clinical Evaluation (35%)

• Develop and prepare Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
• Conduct systematic literature research to support clinical evaluations and regulatory submissions

Post Market clinical follow up activities (30%)

• Assist in the development and execution of PMCF plans and reports
• Collect, analyze, trend, and report on safety data

Clinical Studies activities (25%)

• Organize and execute pre and post-market clinical trials

Collaboration (10%)

• Collaborate with product managers, regulatory affairs managers, and other team members

What you’ll need:

• Experience in developing Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs)
• Strong skills in conducting systematic literature research
• Ability to develop and execute PMCF plans and reports
• Proficiency in safety data analysis and reporting
• Experience in organizing and executing clinical trials
• Excellent collaboration skills with cross-functional teams

Why you should apply:

Join us to be part of a dynamic team that is at the forefront of clinical affairs. You will have the opportunity to work on innovative projects to create the next generation of our devices, ensuring compliance with changing regulations and contributing to continuous improvement activities. This role offers a chance to make a significant impact on product development and market clearance processes.

You will be working in the EMEA HQ of a market leader amongst 30+ different nationalities.

Home working possibilities for 2 days a week