Senior Clinical Research Associate (Medical Devices)

TL;DR

Senior Clinical Research Associate (Medical Devices): Overseeing clinical investigations for medical devices with an accent on regulatory compliance, site management, and data quality. Focus on supporting study planning, driving operational excellence, and maintaining stakeholder relationships across the Netherlands.

Location: Must be based in the Netherlands and willing to travel for site visits

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across various sectors including Life Sciences and Engineering.

What you will do

• Perform site feasibility, qualification, initiation, routine monitoring, and close-out visits.
• Ensure clinical investigations comply with ISO 14155, ICH-GCP, and MDR regulations.
• Monitor site performance, patient safety, and data quality.
• Build and maintain relationships with investigators, sponsors, and cross-functional teams.
• Identify operational risks and drive issue resolution.
• Support Clinical Project Managers with study planning and project execution.

Requirements

• Master's degree or higher in Life Sciences, Biomedical Sciences, or a related field.
• At least 5 years of experience as a Clinical Research Associate, preferably in the Medical Device industry.
• Strong knowledge of ISO 14155, MDR, and ICH-GCP.
• Fluent in English and Dutch.
• Willingness to travel throughout the Netherlands for site visits.

Culture & Benefits

• Diverse and challenging clinical projects within an international consulting environment.
• Continuous learning and career development through dedicated training and coaching.
• Collaborative, entrepreneurial, and multicultural company culture.
• Competitive salary and attractive benefits package.
• Clear career progression opportunities.

Hiring process

• Brief virtual or phone conversation to discuss motivations and fit.
• Approximately 3 interviews with team members and line managers.
• Potential case study or technical assessment depending on the role.