Who We Are

At Nicolab, we connect the physicians and streamline their emergency care workflows, providing physicians with AI-analyzed scans and centralized patient information. 

• Operational in 10+ countries across 4 continents. 

• Established presence in Europe and Australia. Quickly expanding to China, the Middle East, and the rest of Europe and Australia. 

• 30+ employees across the world, with our headquarters in Amsterdam.

Why We Need You

We need to strengthen our quality team to support growth of the company and its product range in various international markets. The QA & RA officer will ensure continued compliance of our QMS processes to international standards and regulations (ISO 13485, MDR & FDA QMSR) and maintain current and support new registrations of Nicolab’s product portfolio in target markets.

The Ideal Candidate 

You have experience as a Quality and Regulatory Officer in SaMD (Software as a Medical Device) or related field. You have a passion for processes and are driven to implement compliant practices throughout the entire company.  You have experience working in an ISO 13485 and MDR compliant management system. You are always looking for innovative approaches to establish and maintain compliance to regulations and requirements and keep our quality management system efficient and lean. You thrive in supporting the company's commercial activities by ensuring timely registration of products in different markets and maintaining compliance. 

• BSc degree or higher in science, engineering, medicine, law or language;

• 1+ years of experience as Quality and Regulatory Officer in the MedTech industry or other strictly regulated industry;

• Knowledge and experience with ISO 13485 Quality Management Systems;

• Knowledge and experience with regulatory submissions and registration maintenance (MDR, FDA etc.);

• Affinity to regulations and processes;

• Excellent communication skills in English, written and oral, additional languages are a plus;

What You’ll Do (Tasks & Responsibilities)

Maintain Quality of the product and product related QMS processes by.. 

• Maintain compliance of Nicolabs QMS processes;

• Update our QMS for new markets;

• Organize internal & external audits;

• Handling of Complaints, Nonconformities and CAPAs;

• Manage Document Control;

• Support Product labelling;

• Organize management review;

• Vigilance reporting;

• Ensure upkeep of our current international product registrations;

• Support registrations of new products and registration in new markets by: 

     - Developing regulatory strategies

     - Assembling of technical documentation