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!

Job description Job Description

 

In this role, you will tackle the complexities of clinical development, focusing on risk management and benefit-risk analysis. Your expertise will contribute to the safety and efficacy of cutting-edge medical products. Working in a dynamic environment, you will collaborate with internal and external stakeholders to deliver high-quality clinical evidence supporting regulatory submissions and product lifecycle management.

  Your Missions Conduct benefit-risk analysis and contribute to risk management throughout product lifecycles. Collect, appraise, and analyze clinical data related to medical products. Prepare clinical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up Reports (PMCF). Collaborate with internal teams (regulatory, statisticians, post-market surveillance, risk management) and external stakeholders (clinical consultants, regulatory agencies) to ensure comprehensive clinical evidence analysis. Ensure the proper dissemination of clinical evidence through Clinical Study Reports (CSRs), CERs, and PMCF Reports. Support clinical trials and product approvals in the USA, EU, and other regions. Lead clinical risk assessments from ideation to market introduction. Optimize workflows, standard operating procedures (SOPs), and document preparation processes for the Clinical Development department.   Your Profile Advanced degree (M.D., Master’s, or Ph.D.) in Biomedical Science or a related health field. 7–10 years of experience in clinical affairs within the medical device or pharmaceutical industry. Strong expertise in benefit-risk analysis and clinical risk management. Experience in vigilance reporting and harm reviews for medical products. Proficiency in medical writing, systematic reviews, and clinical data appraisal (experience with MDR-compliant CERs and PMCFs is a plus). In-depth knowledge of GCP, ICH guidelines, ISO14155, FDA regulations, and EU medical regulations. Experience in clinical investigations design, biostatistics, and research methodology. Proven track record of delivering clinical results on time, within budget, and in compliance with SOPs and regulatory requirements. Strong collaboration skills with multidisciplinary teams and external partners. Fluent in English (additional languages are a plus).  

 

What We Offer An opportunity to work in a fast-paced, innovative environment shaping the future of healthcare. A collaborative culture that values continuous learning and professional development. Exposure to international markets and regulatory landscapes. The ability to make a meaningful impact on patient safety and medical advancements.