- 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 K, PMA and Pre-submissions)
- 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.)
- 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
- We are looking for a person with a Master degree in a scientific discipline such as Biomedical, Pharmacy , 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.
- 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.
-
Regulatory Officer
7 uur geleden
Barco Kortrijk, België**Date**:Mar 8, 2024 · **Location**: Kortrijk, BE · **Company**:Barco · **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 mar ...
-
Regulatory Officer
2 weken geleden
Barco Kortrijk, BelgiëMain 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. ...
-
Regulatory Affairs Officer
1 week geleden
Ecolab Ieper, BelgiëIndependence level/Reports to: General supervision. Normally Reports to Regulatory Affairs Manager. · **Our Commitment to Diversity and Inclusion** · At Ecolab, we believe the best teams are diverse and inclusive, and we are on a journey to create a workplace where every associat ...
-
Regulatory Affairs Officer
3 weken geleden
CID LINES NV Ieper, BelgiëAt CID LINES, an Ecolab Company we believe that hygiene leads to better health, which in turn is the key to greater profitability and sustainability. In the agricultural sector and food industry, health and safety generate better operations in compliance with all regulations. Ove ...
-
Regulatory Affairs Officer
3 dagen geleden
Ecolab Ieper, BelgiëREGULATORY AFFAIRS OFFICER · At CID LINES, an Ecolab Company we believe that hygiene leads to better health, which in turn is the key to greater profitability and sustainability. In the agricultural sector and food industry, health and safety generate better operations in complia ...
-
Regulatory Affairs Officer
7 uur geleden
Cooper Consumer Health Gent, BelgiëRequisition ID · - 39 · - Job Family 1- Regulatory & PSRM · - Country 1- Belgium · - Location 1- Hybrid · - About us · - **Cooper Consumer Health** is a leading European consumer healthcare player that develops, produces, and distributes a diverse range of OTC (over-the-counter) ...
-
Regulatory Affairs Officer
2 dagen geleden
Ecolab Ieper, België**What we are looking for**: · Scientific background in environmental sciences (toxicology, ecotoxicology, chemistry, pharmacy, biology...): bachelor or master degree · As a fluent communicator the English language is indispensable to you, other languages adorn you (French, Itali ...
-
Regulatory Affairs Officer
3 dagen geleden
Nuwhï Gent, BelgiëDo you want to be an expert in **medical affairs** - **market access** and **regulatory affairs**? · We have a great opportunity to be able to learn and to get an expert in these fields. · The great thing about it, is that this mix of RA and Medical affairs or Market access is no ...
-
Regulatory Data and Quality Management Officer
1 week geleden
BASF Belgium Coordination Center Comm.V. Gent, BelgiëAgriculture plays a fundamental role in fulfilling many of humanity's basic needs: food, feed, energy. To support growers and those who take care of our environment, BASF develops innovative solutions for farming, pest control and landscape management - so that we can effectively ...
-
Inside Sales Representative
2 weken geleden
Teledyne FLIR Marke, BelgiëBe visionary · Teledyne Technologies Incorporated provides enabling technologies for industrial growth markets that require advanced technology and high reliability. These markets include aerospace and defense, factory automation, air and water quality environmental monitoring, e ...
-
Qhse Administrator
1 week geleden
GEOxyz Zwevegem, BelgiëGEOxyz is an independent company specialized in hydrographic, geophysical & geotechnical and topographical surveys, site investigations, off shore renewable energy support and crew transfers. The Company operates primarily in the North Sea basin and liaises with highly qualified ...
-
Safety Manager
1 week geleden
Perrigo Wevelgem, België**Wie zijn wij?**: · Join Perrigo Company, where we are dedicated to making lives better by providing high-quality and affordable self-care products that consumers trust. · We are currently seeking an EHS Manager to lead employee development at our pharmaceutical and cosmetics fa ...
-
Safety Manager
2 weken geleden
Perrigo Wevelgem, België**Wie zijn wij?**: · Join Perrigo Company, where we are dedicated to making lives better by providing high-quality and affordable self-care products that consumers trust. · We are currently seeking an EHS Manager to lead employee development at our pharmaceutical and cosmetics fa ...
-
Production Manager
3 weken geleden
Perrigo Wevelgem, BelgiëPerrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it. · **Wie zijn wij?**: · Perrigo Wevelgem, part of the global Perrigo Group, and operates in the pharmaceutical, medi ...
-
Regional Quality Assurance Manager
1 week geleden
Scaldis Part of Elis Belgiek, BelgiëELIS, a leading European industrial services group in its market (170 service and production centers, nearly 50,000 employees in 28 countries), specializes in the rental of professional clothing, têxtile maintenance items and equipment. in hygiene and well-being. · **Job Purpose* ...
-
Site Fsqr Coordinator
3 weken geleden
Cargill France Izegem, BelgiëWant to build a stronger, more sustainable future and cultivate your career? Join Cargill's global team of 160,000 employees who are committed to safe, responsible and sustainable ways to nourish the world. This position is in Cargill's food ingredients and bio-industrial busines ...
-
QA Specialist
1 week geleden
Cargill France Mouscron, BelgiëWant to build a stronger, more sustainable future and cultivate your career? Join Cargill's global team of 160,000 employees who are committed to safe, responsible and sustainable ways to nourish the world. This position is in Cargill's food ingredients and bio-industrial busines ...
-
Quality Assurance Officer
2 weken geleden
Poulpharm Izegem, BelgiëLocation: Poulpharm Belgium · - At Poulpharm, we believe in the potential of every individual to make a positive impact on veterinary healthcare. Our dedicated team of professionals, including laboratory technologists, animal caregivers, researchers, species experts, marketers, a ...
-
Quality Auditor
1 week geleden
Select Roeselare, BelgiëAs a · **quality auditor **you · **ensure that all processes and delivered parts meet internal & customer requirements,** follow up of the integrated management system requirements deployment and respect in the shopfloor to achieve the customer requirements for product safety and ...
-
Aanmaker Veiligheidsbladen
3 weken geleden
SD Worx Jobs Gent, België**Introductie**: · Heb je een passie voor chemie? · En sta je graag in contact met verschillende partijen? · Dan heeft SD Worx Jobs de vacature voor jou · **Wie zoeken we?**: · De ideale kandidaat ziet er als volgt uit: · - Je bezit een master diploma in een chemisch of aanverwan ...
Regulatory Officer - Kortrijk, België - Barco
Beschrijving
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
• Postmarket activities
• Regulatory Intelligence
Required competencies
Let's "wow" you with