Job description
Are you passionate about transforming clinical data into meaningful insights that improve patient safety and product quality? Do you thrive in a role that combines clinical evaluation, medical safety expertise, and hands-on support for product lifecycle activities? Amaris Consulting is looking for a Clinical Development Scientist to support one of our partners in the medical device industry.
This role plays a key part in generating, assessing, and maintaining clinical evidence—with a strong focus on customer complaint assessment, medical safety, and clinical evaluations/documentation for devices within infant care, breastfeeding, and dermatology.
What You Will Do
Clinical Evaluation & Documentation
- Develop, write, and maintain Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with EU MDR, MEDDEV 2.7/1 rev. 4, and internal procedures.
- Prepare PMCF Plans and Evaluation Reports to ensure robust post-market clinical evidence.
- Conduct systematic literature searches, critical appraisals, and clinical data analyses.
- Support claim substantiation, safety/performance assessments, and benefit–risk evaluations.
Customer Complaints & Medical Safety
- Act as a medical safety expert for safety-related complaints, including assessment of seriousness, expectedness, and device relatedness.
- Perform issue impact assessments, health hazard evaluations, and contribute clinical input to risk management activities (ISO 14971).
- Support post-market surveillance, vigilance processes, and continuous product safety monitoring.
- Provide clinical insight for CAPAs and product-related safety decisions.
Clinical Investigations
- Support pre-market clinical investigations and site-level activities (informed consent, subject eligibility, documentation).
- Coordinate activities at study sites to ensure compliance with protocols and GCP standards.
- Engage with investigators, research staff, and internal teams to ensure high-quality study execution.
Cross-Functional Collaboration
- Work closely with Regulatory Affairs, Quality, R&D, Marketing, PMS/Vigilance, and other teams.
- Contribute to technical documentation, regulatory submissions, and lifecycle management.
What You Bring
Education
- Master’s degree or PhD in Life Sciences, Biomedical Sciences, Medicine, Pharmacy, Public Health, or a related field.
Experience & Skills
- Solid experience in clinical evaluation, clinical affairs, or clinical development in the medical device sector.
- Hands-on experience writing CEP/CER and PMCF documentation, including systematic literature reviews.
- Proven experience in customer complaint assessment, medical safety review, and risk management activities.
- Exposure to clinical investigations or site coordination is a strong plus.
- Knowledge of Class I and Class IIa medical devices is preferred.
- Strong analytical mindset, scientific writing skills, and ability to interpret clinical/real-world evidence.
- Collaborative, structured, and comfortable working in a cross-functional environment.
Why Join Us?
- Contribute to impactful and innovative engineering projects across the Netherlands.
- Join an international consulting environment focused on growth, digital transformation, and continuous learning.
- Collaborate with major global industry leaders across sectors such as technology, manufacturing, and life sciences.
- Enjoy a hybrid work model with a blend of office and remote work (role dependent)
- Work within a diverse, international network supported by global hubs and centers of excellence.
- Benefit from additional perks such as performance bonuses and mobility options including lease cars (role dependent)
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 reason, we welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
If you’re ready to take on a role where clinical expertise meets real-world impact, we would love to hear from you.
Apply today and join us in shaping the future of medical device safety and performance.
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!