Regulatory Affairs Specialist
il y a 4 semaines
Examples: managing the day-to-day activities in the project, providing guidance on project policies and processes, overseeing project management resources, and collaborating with stakeholders to drive projects and programs successful delivery.
Key Roles and Responsibilities, but not limited to are:
Responsibilities:
1. Regulatory Submissions and Project Deadlines:
o Oversee the preparation of regulatory submissions, adhering to applicable guidelines and timelines.
o Monitor program reporting and assist in reporting to functional leadership using Daily Management Key Performance Indicators (KPIs).
o Collaborate with cross-functional teams to align project timelines and deliverables.
o Ensure the successful execution of the PMO's strategy, responsibilities, services, and deliverables.
2. Stakeholder Collaboration and Communication:
o Establish effective collaboration among stakeholders, including clinical, marketing, demand planners, and RA regional managers.
o Communicate project development progress transparently to relevant parties.
o Facilitate regular project status meetings and update stakeholders on milestones.
3. Project Management:
o Ensure the successful execution of the PMO's strategy, responsibilities, services, and deliverables.
o Monitor program reporting and assist in reporting to functional leadership.
o Establish frameworks and standards for program and project management.
o Manage, compile, and monitor program-related financial and KPI dashboards.
o Prepare and present cost-benefit analyses to support business case development and implement immediate process improvements.
o Provide and maintain capacity planning and resource tracking across the RA organization. Oversee project planning, milestone management, scope management, and resource forecasting.
o Update and maintain the risk log, action log, decisions log, and issue register.
o Manage cross-program dependencies and accurately maintain the dependency log.
o Coordinate project closure to distil best practices and ensure lessons learned are documented.
4. Regulatory Guidance and Strategy:
o Provide global regulatory advice to project teams and other stakeholders.
o Support the development and implementation of regulatory strategies and plans.
o Align strategies with business objectives and compliance goals.
o Integrate project management methodologies into regulatory processes.
5. (OPTIONAL) Regulatory Analysis and Risk Assessment:
o Conduct thorough regulatory analysis to identify and assess requirements, opportunities, and risks related to products and markets.
o Understand and interpret technical information and product lifecycles, especially changes impacting the project.
o Mitigate risks by developing contingency plans and ensuring regulatory compliance. Profiel At least 3 years of relevant experience in regulated environment (medical devices preferred)
o Experience in leading, managing and deploying integration programs/ projects
o Hands-on personality, with a positive attitude and thrives to work within a stressful & dynamic environment
o Ability to deal with demanding stakeholders and shown ability to lead and inspire individuals, teams and organizations
o Capability to meet deadlines and ability to report on Project progress
o Strong communicator, English full professional proficiency
o Solid knowledge and understanding of the Medical Device industry and regulations
o Strong and in-depth knowledge on Project Management, Transformation Management, SAP, BPO and Agile or Lean Sigma methods
o Culturally sensitive, results driven, hands-on, excellent team player, self-starter and balanced mature personality.
This position is suitable for remote work. Aanbod Van € 3.000 tot € 3.800 per maand Mogelijkheid tot thuiswerken: 2 dagen Groepsverzekering Bedrijfswagen Tankkaart / Laadpas Maaltijdcheques Smartphone Laptop Internetvergoeding / Abonnement Tussenkomst openbaar vervoer Forfaitaire Kosten Cultuur- en sportcheque Eco Cheque Opleiding Offer Description as a Project Consultant:
• Permanent contract with a competitive salary package including: monthly fixed expense allowance, company car and fuel card (or a monthly gross premium), meal vouchers €8, group and health insurance, mobile phone subscription, and a year-end bonus. This attractive package is complemented by Benefits at Work access, sports & culture vouchers, and eco vouchers.
• Varied and dynamic training offering; consisting of both job-specific and overarching training.
• Regular feedback and contact moments with your assigned HR Business Partner.
• Get to know your fellow consultants at our network events and team-building activities.
• Kickstart your career at USG Professionals with our 2-day Bootcamp
Offer Description as a Freelancer:
Simplify your career with the USG EASY app:
• Personalized project proposals based on your profile and availability.
• Transparent follow-up of your invoicing process.
• All your administration in one app.
-
Regulatory Affairs Specialist
il y a 4 semaines
Zaventem, Belgique Nu Skin Temps pleinKey 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 Specialist
il y a 1 semaine
Zaventem, Flandre, Belgique USG Professionals Science Temps pleinUSG Professionals is seeking a talented Regulatory Affairs Specialist for a client located in the Zaventem region. This position offers the flexibility to work either as a USG Project Consultant or on a Freelance basis.Job Title: Regulatory Affairs SpecialistCompany: USG ProfessionalsThe Regulatory Affairs Specialist plays a critical role in ensuring...
-
Regulatory Affairs Specialist
il y a 2 semaines
Zaventem, Flandre, Belgique Nu Skin Temps pleinKey responsibilitiesAs 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 dossiersEnsure product regulatory compliance for food supplements and food with...
-
International Regulatory Affairs Specialist
il y a 2 semaines
Zaventem, Flandre, Belgique Philips Temps pleinJob Title: International Regulatory Affairs SpecialistInternational RA SpecialistPhilips Image Guided Therapy CorporationZaventem, BelgiumIn this role, you have the opportunity to Be recognized as a key talent in international regulatory filings and procedures (excluding USA and Japan). Potential to transition into an internal Subject Matter Expert in a...
-
Regulatory Affairs Specialist
il y a 4 semaines
Zaventem, Belgique Philips Temps plein**Job Title**: Regulatory Affairs Specialist **Type**: Junior Role **Time**: 40 hours/week **Location**: Zaventem **Expected Start Date**: Q1 2023 **In this role, you have the opportunity to** Be part of the Business Image Guided Therapy Devices International. You will be able to work in a large and complex organization. Therefore, the job at any level...
-
Regulatory Affairs Specialist
il y a 2 semaines
Zaventem, Flandre, Belgique Philips Temps pleinJob Title: Regulatory Affairs SpecialistType: Junior RoleTime: 40 hours/weekLocation: ZaventemExpected Start Date: Q1 2023In this role, you have the opportunity toBe part of the Business Image Guided Therapy Devices International. You will be able to work in a large and complex organization. Therefore, the job at any level demands knowledge, experience and...
-
Manager, Regulatory Affairs
il y a 3 semaines
Zaventem, Belgique NSF International Temps pleinRegulatory Affairs Manager EMEA At NSF International, our mission is to protect and improve human health. We’re a global leader in standards development, testing, auditing, certification and training. We provide these services for a diverse set of industries including food, water, health sciences, sustainability and management systems. We’re passionate...
-
Regulatory Affairs Specialist Benelux
il y a 2 semaines
Zaventem, Flandre, Belgique Haleon Temps pleinHello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep...
-
Manager, Regulatory Affairs
il y a 2 semaines
Zaventem, Flandre, Belgique NSF International Temps pleinRegulatory Affairs Manager EMEAAt NSF International, our mission is to protect and improve human health. We're a global leader in standards development, testing, auditing, certification and training. We provide these services for a diverse set of industries including food, water, health sciences, sustainability and management systems. We're passionate about...
-
Eu Regulatory Affairs Advisor
il y a 1 semaine
Zaventem, Flandre, Belgique Tree Energy Solutions Temps pleinContribute to creating a sustainable tomorrow:For many years, climate change has made it clear that we must engage into gradually phasing out fossil fuels. All organizations, especially those in Europe, need an urgent energy revolution given the current geopolitical climate. At TES, we believe that this is an unprecedented moment to tackle both energy...
-
Regulatory Affairs
il y a 3 semaines
Zaventem, Belgique Zoetis Temps pleinlocations- 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...
-
Regulatory Affairs Senior Associate, Central
il y a 2 semaines
Zaventem, Belgique Zoetis Temps pleinlocations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00014179- Zoetis Belgium is looking for a Regulatory Affairs Senior Associate to support the provision of registration dossiers to our in-country regulatory colleagues for submission to national regulatory authorities throughout the Central & Eastern Europe, Africa and...
-
Regulatory Affairs Senior Associate, Central
il y a 2 semaines
Zaventem, Flandre, Belgique Zoetis Temps pleinlocations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR Zoetis Belgium is looking for a Regulatory Affairs Senior Associate to support the provision of registration dossiers to our in-country regulatory colleagues for submission to national regulatory authorities throughout the Central & Eastern Europe, Africa and Middle...
-
Regulatory Affairs Project Manager
il y a 1 jour
Zaventem, Belgique Randstad Travail à distance Freelance Temps pleinDo you have demonstrable experience as a project manager in Regulatory Affairs and experience with medical devices? We are looking for you for a company located in Zaventem!As a Regulatory Affairs Project Manager (RAPM), you will be responsible for guideline compliance and successful execution of regulatory requests. In addition to regulatory expertise, RAPM...
-
Regulatory Affairs Project Manager
il y a 1 jour
Zaventem, Flandre, Belgique Randstad Temps pleinDo you have demonstrable experience as a project manager in Regulatory Affairs and experience with medical devices? We are looking for you for a company located in ZaventemAs a Regulatory Affairs Project Manager (RAPM), you will be responsible for guideline compliance and successful execution of regulatory requests. In addition to regulatory expertise, RAPM...
-
Specialist Vergunningen en Regulatory Affairs
il y a 1 semaine
Zaventem, Belgique Eurofiber Temps plein**Vacatureomschrijving**: Ter versterking van ons team zijn we op zoek naar een specialist vergunningen en regelgeving. Kun je zeer georganiseerd werken en heb je oog voor detail? Solliciteer dan vandaag nog. In deze functie ben je verantwoordelijk voor het beheren en verkrijgen van vergunningen voor diverse projecten. Je hebt dan ook de vaardigheden om...
-
Regulatory Affairs Project Manager
il y a 4 semaines
Zaventem, Belgique Randstad Travail à distance Freelance Temps pleinAre you open to a role as a Regulatory Affairs Project Manager in an international company in medical devices?The Regulatory Affairs Project Manager (RAPM) is responsible for ensuring compliance with regulatory guidelines and successful execution of regulatory submissions. In addition to regulatory expertise, the RAPM integrates project management...
-
Regulatory Affairs Project Manager
il y a 2 semaines
Zaventem, Flandre, Belgique Randstad Temps pleinAre you open to a role as a Regulatory Affairs Project Manager in an international company in medical devices?The Regulatory Affairs Project Manager (RAPM) is responsible for ensuring compliance with regulatory guidelines and successful execution of regulatory submissions. In addition to regulatory expertise, the RAPM integrates project management principles...
-
Regulatory Affairs Project Manager
il y a 4 semaines
Zaventem, Flandre, Belgique Randstad Temps pleinAre you open to a role as a Regulatory Affairs Project Manager in an international company in medical devices?The Regulatory Affairs Project Manager (RAPM) is responsible for ensuring compliance with regulatory guidelines and successful execution of regulatory submissions. In addition to regulatory expertise, the RAPM integrates project management principles...
-
Specialist Vergunningen en Regulatory Affairs
il y a 1 semaine
Zaventem, Flandre, Belgique Eurofiber Temps plein**Vacatureomschrijving**:Ter versterking van ons team zijn we op zoek naar een specialist vergunningen en regelgeving. Kun je zeer georganiseerd werken en heb je oog voor detail? Solliciteer dan vandaag nog. In deze functie ben je verantwoordelijk voor het beheren en verkrijgen van vergunningen voor diverse projecten. Je hebt dan ook de vaardigheden om...
