Clinical Research Associate - Medical Devices (F/M/X)

We are looking for an experienced Clinical Research Associate (CRA) with a strong background in medical devices to support several of our clients across the Medical Device and Life Sciences industry. As a CRA, you will be responsible for supporting clinical investigations throughout their lifecycle, working with study teams, investigators, clinical sites and other stakeholders. You will typically work on sponsor-dedicated projects, supporting clinical studies involving Class I, Class II and Class III medical devices. The role offers exposure to different clients, technologies and clinical environments while allowing you to apply your clinical research expertise within a consulting setting.

Key Responsibilities

• Support the planning, execution and follow-up of clinical investigations for medical devices.
• Perform site selection, initiation, monitoring and close-out activities in accordance with study requirements.
• Conduct routine monitoring visits and ensure appropriate follow-up of clinical sites.
• Ensure clinical studies are conducted in compliance with Good Clinical Practice (GCP) and ISO 14155.
• Support study start-up activities, including site qualification, regulatory documentation and essential documents.
• Review and maintain Trial Master File (TMF) and Investigator Site File (ISF) documentation.
• Monitor clinical data and documentation for completeness, accuracy and compliance.
• Identify, document and follow up on protocol deviations, non-compliances and other study issues.
• Collaborate with investigators, study coordinators, sponsors, medical experts and cross-functional project teams.
• Support the management and reporting of safety events and device-related incidents in accordance with applicable requirements.
• Contribute to clinical study reports, monitoring reports and other clinical documentation.
• Support audits and inspections where required.
• Provide regular study status updates and escalate risks or issues appropriately.

Your Profile

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Sciences, Nursing, Pharmacy, Medicine or a related discipline.
• Proven professional experience as a Clinical Research Associate within the Medical Device industry is required.
• Experience with clinical investigations involving Class I, Class II and/or Class III medical devices.
• Strong knowledge of ISO 14155 and Good Clinical Practice (GCP).
• Understanding of the EU Medical Device Regulation (MDR) and the clinical evaluation framework.
• Experience with clinical trial documentation, TMF/ISF and monitoring activities.
• Strong understanding of clinical study processes from study start-up through close-out.
• Excellent communication and stakeholder-management skills.
• Ability to work independently while collaborating effectively with international project teams.
• Willingness to travel to clinical sites when required.
• Professional proficiency in English; Dutch is a plus.

What We Offer

• The opportunity to work on multiple medical device projects and technologies across different clients.
• Exposure to both Class I–III medical devices and different stages of clinical development.
• A consulting environment combining technical expertise with varied project experience.
• Opportunities to develop your expertise in clinical research, medical device regulations and clinical investigations.
• Access to training, knowledge-sharing and professional development opportunities.
• An international and multidisciplinary working environment.
• A competitive salary and benefits package, aligned with your experience.

Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.

Who are we?

Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:

Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!