Regulatory Affairs Specialist

il y a 2 semaines


Zaventem, Belgique Philips Temps plein

**Job Title**:
Regulatory Affairs Specialist
**In this role, you have the opportunity to**

be recognized as a key talent in International Regulatory filings for Philips Image Guided Therapy, medical device products and procedures and be considered as a key point for enabling the regulatory compliance in the Markets. In this job, you support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines. We are expanding the department due to growth and development.

**You are responsible for**
- Setting up and maintaining all regulatory files
- Verifying overview of regulatory status in all countries of Europe, AFLAME & APAC
- Verification with Sales and Marketing team
- Creating an action plan for new products to be registered
- Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local Regulatory requirements for CE marked/FDA cleared devices in the countries of IGT-D distribution (Europe, AFLAME & APAC) to ensure that Philips IGT-D products comply with the regulations
- Coordinating documents (CE certifications, Declaration of Conformities, IFU’s,.) to obtain requested licenses, notarizations, apostille, foreign embassy authentications
- Follow up on registration process in International regions
- Filing of all registration documents
- Informing dedicated groups of interest
- Approval process in WindChill and SAP
- Creating product files for submissions
- Contact with distributors to verify Product Change Notifications
- Follow up on new regulations in all regions.
**You are a part of**

As RA specialist, you will report to the Q&R Manager, IGT Devices International.

**To succeed in this role, you should have the following skills and experience**
- Bachelor’s degree in relevant field (BS, MS, or PhD in Engineering or Science preferred.)
- At least 2-5 years of experience in Regulatory Affairs
- Familiarity with preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide preferred.
- Working knowledge of medical device regulations (21CFR), FDA law, EU MDR. Preferrably experience in multiple types of International regulatory submissions
- Some experience in supporting international registrations and clinical investigations would be preferred.
- Ability to makes decisions in a timely manner and under tight deadlines.
- Excellent verbal and written communication skills (English)
**In return, we offer you**

to a challenging, innovative environment with great opportunities for you to explore.

Our benefits are very competitive and designed around your preferences:

- A market conform salary
- 25 Days of leave and the possibility to purchase up to 20 extra days off annually
- A variable bonus based on both Philips results and personal performance
- Extensive set of tools to drive your career, such as a personal development budget, free training and coaching
- Solid company pension scheme and attractive collective health insurance package
- Opportunity to buy Philips shares and products with discount
- Healthy work-life balance
**How we work at Philips**

Our newly adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart - which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home - for our hybrid roles.

Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.

We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.

We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

**Why should you join Philips?**

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on
innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

LI-EU


  • Regulatory Affairs Specialist

    il y a 2 semaines


    Zaventem, Belgique Nu Skin Temps plein

    Key responsibilities As a Regulatory Affairs Specialist for our food and food supplement brands you will report to the Regulatory Affairs Manager. Your responsibilities will include, amongst others: - On-time filing of regulatory submissions and post-approval maintenance of regulatory dossiers- Ensure product regulatory compliance for food supplements and...

  • Regulatory Affairs

    il y a 6 jours


    Zaventem, Belgique Zoetis Temps plein

    locations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00010928- For our office in Zaventem, Zoetis is currently looking for a _Regulatory Affairs & Compliance, Associate Manager / Manager._ - JOB PURPOSE: - In collaboration with the RA team members, the RA&C Associate - Mgr / Mgr contributes to the Regulatory day-to-day...

  • Public Affairs Officer

    il y a 5 jours


    Zaventem, Belgique Etex Group Temps plein

    As Public Affairs Officer, you are a key contributor to **shape** the Public Affairs function at Etex, which was recently created. By **building the bridge** between the multiple and diverse regulatory developments (e.g., in the framework of the EU’s Green Deal) and the ambitions and priorities of Etex, you directly impact the way Etex operates to...


  • Zaventem, Belgique Nu Skin Temps plein

    About the internship In this role you will take on responsibilities in the Regulatory Affairs team. Your responsibilities will include: - Administrative work, such as document collection and filing - keeping administration up to date, managing document archive- Collaborate with internal and external stakeholders- Interact with project teams and suppliers...

  • Eu Affairs Advisor

    il y a 6 jours


    Zaventem, Belgique IKEA Temps plein

    WHO YOU ARE Who you are: You see things a little differently. So do we. We believe in discovering and developing the talent in each of us. We offer positions that challenge your skills and inspire you to grow. Come see things a little differently with us. We are looking for someone that is passionate about public affairs and communication and has a natural...

  • Medical Affairs Manager

    il y a 2 semaines


    Zaventem, Flandre, Belgique Nuwhï Temps plein

    Therapeutic Area Lead Oncology/Hematology – BelgiumAre you a seasoned leader in Medical Affairs with expertise in oncology and/or hematology? Do you have a passion for developing high-performing teams and driving medical strategy in a cutting-edge biotechnology environment? If so, this Therapeutic Area Lead role could be the perfect opportunity for...


  • Zaventem, Belgique Microsoft Temps plein

    Are you insatiably curious and do you lean into uncertainty, take risks, and learn quickly from? Are you passionate about cybersecurity and compliance? Do you enjoy working on a high-performing, fast-paced sales team? Are you insatiably curious and do you lean into uncertainty, take risks, and learn quickly from your mistakes? Are you ready to join the team...


  • Zaventem, Belgique IQVIA Temps plein

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Hybrid role, requiring Dutch language...


  • Zaventem, Belgique KPMG Temps plein

    Advisory - Junior Advisor**Location**: - Zaventem HQ**Roles & Responsibilities**: - Do you have a masters’ degree in law, and would you like to explore career opportunities other than joining a law firm? Find out here below why we will be the #1 Regulatory practice in Belgium within the next few years and why you should be part of our journey.**What do...


  • Zaventem, Belgique IQVIA Temps plein

    **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. **Fluent in both English and Dutch or...


  • Zaventem, Belgique ABB Temps plein

    **Vice President and Head of European Union Government Relations and Public Affairs, Brussels**: **Take your next career step at ABB with a global team that is energizing the transformation of society and industry to achieve a more productive, sustainable future. At ABB, we have the clear goal of driving diversity and inclusion across all dimensions: gender,...


  • Zaventem, Flandre, Belgique KPMG Belgium Temps plein

    At KPMG Belgium, we are seeking an Information Management Specialist to support the implementation and ongoing operations of our information management strategy.Key Responsibilities:Draft and implement an information management policy, procedures and governance model including a document lifecycle strategy.Assist in the evaluation and selection of...

  • Payroll Specialist

    il y a 3 jours


    Zaventem, Belgique IKEA Temps plein

    **Job ID**: 275599 **Date posted**: 24/01/2025 **Who you are** - Payroll team at People & Culture at IKEA of Belgium, is looking for a Total Rewards Specialist (Payroll Specialist). At IKEA Belgium, you will work in a truly international and dynamic environment. You will have different opportunities to learn new skills and where the goal always is to...

  • QA Specialist

    il y a 4 semaines


    Zaventem, Belgique Thermo Fisher Scientific Temps plein

    **Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Summarized Purpose**: At Thermo Fisher Scientific, we offer an outstanding opportunity for a Quality Assurance Specialist to join our ambitious Research team. This role is pivotal in ensuring the flawless execution of our world-class scientific projects. Your contributions will...


  • Zaventem, Belgique IQVIA Temps plein

    **Veterinary Diagnostics Specialist - Wallonia** Pour une entreprise de santé animale internationale, nous sommes à la recherche d’un « chasseur » commercial **Tâches** Générer des ventes auprès **des clients existants** et à tous les clients potentiels de la santé des animaux dans votre région désignée Expliquer clairement les...


  • Zaventem, Belgique IKEA Temps plein

    Who you are - Payroll team at People & Culture at IKEA of Belgium, is looking for a Total Rewards Specialist (Payroll Specialist). At IKEA Belgium, you will work in a truly international and dynamic environment. You will have different opportunities to learn new skills and where the goal always is to create a better everyday life for the many people. To be...

  • Payroll Expertise Manager

    il y a 6 jours


    Zaventem, Flandre, Belgique IKEA Belgium Temps plein

    Job DescriptionAs a Total Rewards Specialist (Payroll Specialist), you will be responsible for investigating and resolving payroll issues while ensuring strict compliance with company and regulatory standards.You will work closely with the store unit P&C Management, HR, and People Planners to maintain personnel databases, process payroll, and prepare...

  • Payroll Specialist

    il y a 3 semaines


    Zaventem, Flandre, Belgique CareerWallet Temps plein

    IKEA is all about people, and our team make sure to bring the best people on board to keep our strong spirit of togetherness. We believe that different experiences and backgrounds collectively make us wiser and stronger, and we ensure that our co-workers bloom into their best selves as they contribute to our business. In the role as Total Rewards Specialist...

  • Payroll Specialist

    il y a 6 jours


    Zaventem, Flandre, Belgique IKEA Belgium Temps plein

    IKEA is all about people, and our team make sure to bring the best people on board to keep our strong spirit of togetherness. We believe that different experiences and backgrounds collectively make us wiser and stronger, and we ensure that our co-workers bloom into their best selves as they contribute to our business. In the role as Total Rewards Specialist...

  • Product Marketing Assistant

    il y a 1 semaine


    Zaventem, Belgique Nu Skin Temps plein

    Description **About us** **Introduction** Looking to sink your teeth into the world of **product marketing**? With a friendly international culture and a drive to do great things, you'll find no better start than Nu Skin. We are looking for a motivated product marketing assistant to join the team and support us with our skin care and food supplement...