Regulatory Officer

Main accountabilities
As a regulatory Officer, you will be setting the regulatory framework and strategy by developing global regulatory pathways to bring new Medical Devices and Medical software to market.  You will be engaged in the full lifecycle of the products and software.

You will evaluate global regulatations and lead the organization to understand and communicate on Global Regulatory requirements and drive regulatory improvement intitatives to increase efficiency and effectiveness of the end to end processes.    

We are looking for a creative mind to develop solution and address anticipated obstacles.  As Barco is growing its portfolio in Medical software and AI , relevant experience and interest is highly appreciated . 

•    Regulatory framework and strategy 

• Identifies global regulatory pathway for initial product designs and works with internal stakeholders to determine the final global regulatory strategy
• Ability to develop a global regulatory strategy through innovative procedures to ensure smooth route to market
• Develops and manages programs to train stakeholders on current and new regulations to ensure company-wide compliance
• Identifies the need for new regulatory procedures and manages their development, approval and execution
• Acts as regulatory responsible contact towards authorities and external parties (like FAGG, FDA, Notified Body…)
• Provides regulatory guidance on strategy for proposed product claims and ensures that clinical and non-clinical data to support claims are in line with regulatory requirements
• Prepares and submits registration dossiers at competent authorities worldwide  (technical documentation with EU notified body, FDA 510K, PMA and Pre-submissions)
   

•    Postmarket activities

• Reviews and approves required reports and other additional post market commitments to maintain product registration 
• Ensures process is in place for review and approval of advertisement and promotional material to ensure regulatory compliance 
• Evaluates serious complaints from the market, submits and follows up corresponding reports to the Authorities (FDA, Health Canada, EU Competent Authorities etc.)

•    Regulatory Intelligence 

• Performs / supervises regulatory due diligence and identifies its key opportunities
• Spokesperson on regulatory topic during audits and inspections 
• Evaluate international regulations, guidance documents and standards to mitigate regulatory risks to ensure compliance

Required competencies

• We are looking for a person with a Master degree in a scientific discipline such as Biomedical, Pharmacy , ...or Engineering domain 
• Ability to translate regulatory, scientific, operational and business knowledge into effective implementation plans 
• Profound knowledge of the worldwide medical device and in vitro diagnostic regulations (EU MDR, FDA, ...) and able to analyze and synthetize knowledge
• Excellent verbal and written communication skills, listening skills and able to cope with stressful situations
• Sound judgement and high level of integrity and ethics. Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
• Analytical, investigative and decision-making skills
• Ability to deal with and manage a diverse and demanding workload
• Ability to work in teams and willing to travel up to 20% of the time. 

Let's "wow" you with

• A variety of inhouse trainings at our Barco University so you can continuously grow & learn as a professional.
• A healthy working environment with interesting workshops, sport activities, diverse & fresh lunch/snack breaks - with our own coffee bar and restaurant in Kortrijk - and many more options as we care about your wellbeing. 
• The opportunity to work for an international market leader where innovation matters.