We are looking for a Medical Safety & Complaint Handling Specialist to join our Medical Affairs team supporting innovative healthcare products. In this role, you will play a key part in ensuring product safety by evaluating customer complaints, supporting regulatory compliance, and contributing to post-market surveillance activities.
You will work closely with cross-functional teams including Medical Affairs, Quality, Regulatory Affairs, Clinical Development and R&D, providing scientific and medical expertise throughout the product lifecycle.
This position is ideal for someone who enjoys combining scientific reasoning with structured documentation and has a strong interest in medical device safety.
- Manage and assess customer complaints related to medical devices.
- Perform medical and scientific evaluations to determine complaint severity, potential root cause and product relationship.
- Support Post-Market Surveillance (PMS) and vigilance activities.
- Contribute to safety assessments and risk management documentation.
- Prepare and maintain clinical and safety-related documentation.
- Collaborate with Regulatory Affairs, Quality, R&D and Clinical teams to ensure compliance with applicable regulations.
- Support investigations related to adverse events and customer feedback.
- Participate in continuous improvement initiatives for complaint handling and safety processes.
- Ensure documentation complies with internal quality standards and global regulatory requirements.
- Master's degree or PhD in Medicine, Biomedical Sciences, Pharmacy, Clinical Sciences, Life Sciences or a related field.
- Experience within the medical device, healthcare or life sciences industry.
- Strong analytical skills and ability to interpret scientific and medical information.
- Excellent written communication skills with experience preparing technical or scientific documentation.
- Ability to work independently while collaborating effectively with multidisciplinary teams.
- Fluent in English (written and spoken).
- Medical degree (MD) or comparable clinical background.
- Experience with Complaint Handling, Vigilance, Medical Affairs or Post-Market Surveillance.
- Knowledge of Medical Device Regulation (MDR), ISO 14971 and applicable quality management systems.
- Experience with risk management or product safety evaluations.
- Familiarity with FDA Medical Device reporting requirements is considered an advantage.
We're looking for someone who:
- Enjoys solving complex scientific and medical questions.
- Has excellent attention to detail.
- Likes structured, documentation-driven work.
- Is comfortable making evidence-based decisions.
- Can balance scientific judgement with practical business needs.
- Communicates clearly with both technical and non-technical stakeholders.
- Takes ownership while maintaining a collaborative mindset.
- An opportunity to work on innovative healthcare products that improve patients' lives.
- A collaborative international environment with highly experienced Medical Affairs professionals.
- Exposure to cross-functional projects across Clinical, Regulatory, Quality and R&D.
- Opportunities for professional development and long-term career growth.
- A supportive team focused on knowledge sharing and continuous learning.
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.
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!
