Are you seeking a highly skilled professional to support your clinical and product development projects?

Are you a Senior Medical Device Specialist with extensive experience in (pre-)clinical studies, new product development, clinical biocompatibility, and biological safety? With exceptional analytical abilities and a commitment to delivering results on time, our expert is ready to make a meaningful impact on your projects!

Your area of work

• Biological Assessments: Oversee biological evaluations for new product introductions (NPI) and lifecycle management (LCM) activities, including the development of biological assessment plans and reports, and management of testing conducted by external CROs

  
  

• Cross-functional Collaboration: Work closely with project managers, regulatory affairs (RA), quality assurance (QA), clinical affairs, and other key stakeholders to ensure alignment on strategies, results, and timelines

  
  

• Regulatory & Biological Safety Strategies: Develop regulatory strategies, conduct gap analyses for new and updated standards, and periodically review internal SOPs to ensure compliance

  
  

• Design & Risk Management: Act as a core team member for NPIs, contributing to FMEAs, requirements matrices, regulatory submissions, and design reviews

  
  

• Training & Knowledge Sharing: Deliver training on biocompatibility, focusing on the impact of raw material selection, process changes, and supplier variations

  
  

• Documentation Review & Process Improvement: Review critical project documents, ensure compliance with regulatory standards (e.g., UDI), and improve document and manufacturing quality through Kaizen and problem-solving processes

  
  

• Health Hazard Evaluations (HHE) & CAPAs: Support HHEs and oversee corrective and preventive actions

Your experience

• Extensive experience in biocompatibility, biological safety, and medical device development

  
  

• Strong analytical and project management skills

  
  

• Proven ability to coordinate with cross-functional teams and stakeholders

  
  

• Expertise in regulatory compliance, risk assessment, and biological evaluations

  
  

• A results-driven approach with a focus on delivering high-quality outcomes

  
  

Why EUMEDIQ

EUMEDIQ is committed to providing outstanding expertise in medical device consulting, helping our clients achieve excellence in product development and regulatory compliance. By collaborating with our specialist, you gain access to deep clinical insights, practical solutions, and reliable support tailored to your project’s specific needs.

If you’re looking for a professional who can elevate your clinical and product development initiatives, we’d love to explore how we can work together!

Contact us to learn more about how we can support your success: info@eumediq.eu