Global Clinical Safety & Regulatory Consultant

Amaris Consulting; Groningen; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

International community

Robust training system

Inclusive working environment

Job summary

A dynamic consulting firm in the Netherlands seeks a Clinical Consultant to provide expert clinical and safety support for medical products. This role involves evaluating clinical data, managing risk, and ensuring compliance with regulations. The ideal candidate will have an advanced degree, experience in clinical safety, and be fluent in English. Join a diverse international team and contribute to high-quality patient safety documentation in a supportive environment.

Qualifications

• Advanced degree in a relevant field such as Medicine or Pharmacy.
• Experience in clinical development and safety, including post-market surveillance.
• Ability to analyze and interpret clinical and safety data.

Responsibilities

• Evaluate clinical data and safety information for medical products.
• Prepare Clinical Evaluation Reports (CERs) and Clinical Study Reports (CSRs).
• Conduct post-market surveillance and ensure regulatory compliance.

Skills

Clinical data evaluation

Regulatory compliance

Risk management

Attention to detail

Fluent English

Knowledge of medical device regulations

Education

Advanced degree in relevant field (Master's or PhD preferred)

Tools

Statistical software

Job description

Job Description

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.

Job Description

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.

As a Clinical Consultant at Amaris Consulting, you provide expert clinical and safety support for medical products and devices. You ensure evidence-based decision-making, regulatory compliance, and the protection of patient safety throughout the product lifecycle. This includes evaluating clinical data, managing risk, and generating high-quality documentation to support product development, approvals, and post-market activities.

Your missions

• Evaluate clinical data and safety information for medical products and devices.
• Prepare Clinical Evaluation Reports (CERs), Clinical Study Reports (CSRs), and PMCF documentation.
• Conduct post-market surveillance, adverse event reporting, and risk management.
• Support evidence-based decision-making in product development and safety.
• Apply risk management processes to clinical complaints and safety signals.
• Communicate with internal and external stakeholders, including physicians and regulatory bodies.
• Ensure compliance with USA (FDA), EU (MDR), and other global medical device regulations.
• Analyze clinical literature, adverse event data, and other safety sources.
  
  
  

Your profile

• Advanced degree in a relevant field: Medical Doctor (PRIO), Pharmacy, Life Sciences, Biomedical Sciences, Medicine, or related discipline (Master’s or PhD preferred).
• Experience in clinical development and safety: post-market surveillance, adverse event reporting, risk management.
• Experience with mother and child care products and/or medical devices (such as IPL devices).
• Knowledge of USA (FDA), EU (MDR), and other global medical device regulations.
• Experience preparing CERs, CSRs, and PMCF documentation.
• Ability to analyze and interpret clinical and safety data.
• Experience with clinical and safety databases and statistical software.
• Attention to detail and commitment to patient safety.
• Knowledge of evolving regulations and maintaining compliance with quality standards.
• Professionalism in handling sensitive safety-related inquiries.
• English fluent. Dutch is a plus.
  
  
  

What We Offer

• An international community bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
  
  
  

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 1,000 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!