Regulatory Officer
Barco
- Courtrai, Flandre-Occidentale
- CDI
- Temps-plein
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 work 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 regulation to ensure company wide compliance.
- Identifies the need for new regulatory procedures and manages the development, approval and execution
- Act as regulatory responsible contact towards authorities and external parties like (FAGG, FDA, Notifed body…)
- Provides regulatory guidance on strategy for proposed product claims and ensures that clinical an non-clincal data to support claims are in line with regulatory requirements
- Postmarket activities
- Review 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
- Regulatory Intelligence
- Performs / supervises regulatory due diligence and identifies its key opportunities
- Spokesperson on regulatory topic during audits and inspections
- Evaluate policies to mitigate regulatory risks to ensure compliance.
- Ability to translate regulatory, scientific, operational and business knowledge into effective implementation plans
- Profound knowledge of the worldwide medical device regulations (EU MDR, FDA, ...) and able to analyze and synthtize 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