Your mission
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.
What You Will Do
● Maintain compliance of Nicolabs QMS processes ;
● Update Nicolab’s 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 Nicolab’s current international product registrations ;
● Support registrations of new products and registration in new markets by:
- Developing regulatory strategies
- Assembling of technical documentation
Your profile
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.
What you'll bring
● BSc degree or higher in science, engineering, medicine, law or language;
● 1+ years of experience as Quality and Regulatory Officer in software as a Medical device or related field;
● Knowledge and experience with ISO 13485 Quality Management Systems;
● Knowledge and experience with regulatory submissions and registration maintenance (MDR, FDA etc.);
● Attention to detail;
● Affinity to regulations and processes;
● Excellent communication skills in English, written and oral, additional languages are a plus;
Why us?
We Offer You
● Chance to make a real difference in patients' lives
● Work in a stimulating environment with a motivated team
● Flexible Employment Agreement: Part time / Fulltime / Remote (EOR Contract*)
● Flexible working hours
● Flexible paid time off*
● Remote work policy
● Laptop + home office/IT equipment*
● Commuting to work - costs reimbursement
● Pension plan scheme*
● Employee Stock Option Plan (ESOP)*
● Corporate programs including Employee Referral Program with rewards
● Learning & Development opportunities including in-house training and coaching, professional certifications, and over 22,00 courses on LinkedIn Learning Solutions and much more
*All benefits and perks are subject to certain eligibility requirements
Application Process
● Interview with Recruiter/HR
● Interview with Future Manager (hiring manager)
● Interview with Peers (no managers present)
● Interview with Executive
- Prior employment verification check
About us
Nicolab was founded in 2015 following the acclaimed MR CLEAN trial, the first Randomised Clinical Trial proving the benefit of Endovascular Treatment. The trial led to a global paradigm shift in acute stroke care and triaging, resulting in the hospital Hub and Spoke model.
Leading MR CLEAN researchers and our co-founders, Dr. Merel Boers and Dr. Renan Sales Barros, recognized the need for an AI solution to revolutionize stroke care. With exclusive access to the heterogeneous MR CLEAN dataset, Nicolab developed StrokeViewer. StrokeViewer provides the most accurate AI algorithms to diagnose stroke patients worldwide.
Our background is steeped in leading clinical research, which is why we continue to invest and contribute significantly to research, ensuring that Nicolab remains at the forefront of driving innovative change and improving outcomes for stroke patients.
While Nicolab continues to run its operations with Headquarters in Amsterdam, The Netherlands, we are proudly an Australian-based publicly unlisted company with an expanding global presence.
Visit our website:
Nicolab.com
