Medical Safety & Complaint Handling Specialist; F​/M​/X

Medical Safety & Complaint Handling Specialist (F/M/X)

Permanent Job,Temporary Job

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 with in 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.
• 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…