Regulatory Affairs Project Manager
il y a 3 jours
Do 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 integrates project management principles to drive efficient processes and achieve project milestones. Examples: managing day-to-day activities in the project, providing guidance on project policies and processes, overseeing project management resources and working with stakeholders to successfully complete projects and programmes.Â
We offer you a challenging assignment through Randstad Professionals - Life Sciences for a period of 7 months.
key responsibilities
1. Regulatory applications and project deadlines:
- Oversee preparation of regulatory requests and adhere to applicable guidelines and timelines.
- Monitor programme reporting and assist in reporting to functional leadership using Key Performance Indicators (KPIs) for day-to-day management.
- Collaborate with cross-functional teams to align project timelines and deliverables.
- Ensure successful execution of PMO's strategy, responsibilities, services and deliverables.
2. Collaboration and communication with stakeholders:
- Establish effective collaboration between stakeholders, including clinical, marketing, demand planners and regional RA managers.
- Communicate project development progress transparently to relevant parties.
- Facilitate regular project status meetings and keep stakeholders informed of milestones.
3. Project management:
- Ensure the successful implementation of the PMO's strategy, responsibilities, services and deliverables.
- Monitor programme reporting and assist in reporting to functional leadership.
- Establish frameworks and standards for programme and project management.
- Manage, compile and monitor programme-related financial and KPI dashboards.
- Prepare and present cost-benefit analyses to support business case development and implement direct process improvements.
- Provide and maintain capacity planning and resource tracking within the RA organisation. Oversees project planning, milestone management, scope management and resource forecasting.
- Update and maintain the risk log, action log, decision log and problem log.
- Manage cross-programme dependencies and maintain accurate dependency log.
- Coordinate project closure to distil best practices and ensure lessons learned are documented.
4. Regulatory guidance and strategy:
- Provide global regulatory advice to project teams and other stakeholders.
- Support the development and implementation of regulatory strategies and plans.
- Align strategies with business objectives and compliance goals.
- Integrate project management methods into regulatory processes.
5. Regulatory analysis and risk assessment:
- Conduct thorough regulatory analysis to identify and assess requirements, opportunities and risks related to products and markets.
- Understand and interpret technical information and product life cycles, especially changes affecting the project.
- Mitigate risks by developing contingency plans and ensuring regulatory compliance.
qualifications
- Minimum 3 years of relevant experience in a regulated environment (project management RA medical devices)
- Strong communicator, full professional proficiency in English
- Thorough knowledge and understanding of the medical device industry and regulatory environment
- Strong and in-depth knowledge of Project Management, Transformation Management, SAP, BPO and Agile or Lean Sigma methodologies
- Experience in leading, managing and implementing integration programmes/projects
- Ability to meet deadlines and report on project progress
key benefits
We offer you an interesting salary package and a contract with Randstad Professionals (clerical or freelance).
- Gross salary depending on your personal situation
- Extra net allowance â¬80 per month, on top of your net salary
- Mileage allowance or option for company car (subject to conditions)
- Meal vouchers worth â¬140 for 20 days worked
- Eco cheques of â¬250 per year
- Holiday pay and 13th month
- 12 extra holidays per year
- Hospitalisation insurance with DKV
- Pension savings
We also offer numerous training courses, fun activities, advancement opportunities, ... to guide you through your career.
-
Regulatory Affairs Project Manager
il y a 3 jours
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...
-
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...
-
Regulatory Affairs Specialist
il y a 2 semaines
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...
-
Manager, Regulatory Affairs
il y a 4 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
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 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...
-
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...
-
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 Project Manager
il y a 4 jours
Zaventem, Flandre, Belgique Randstad Temps pleinHeb jij aantoonbare ervaring als project manager in Regulatory Affairs en ervaring met medical devices? Voor een bedrijf gelegen te Zaventem zijn we op zoek naar jouAls Regulatory Affairs Project Manager (RAPM) ben je verantwoordelijk voor het naleven van de richtlijnen en het succesvol uitvoeren van regelgevingsaanvragen. Naast expertise op het gebied van...
-
Regulatory Affairs Project Manager
il y a 4 jours
Zaventem, Belgique Randstad Travail à distance Freelance Temps pleinHeb jij aantoonbare ervaring als project manager in Regulatory Affairs en ervaring met medical devices? Voor een bedrijf gelegen te Zaventem zijn we op zoek naar jou!Als Regulatory Affairs Project Manager (RAPM) ben je verantwoordelijk voor het naleven van de richtlijnen en het succesvol uitvoeren van regelgevingsaanvragen. Naast expertise op het gebied van...
-
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 Manager
il y a 2 semaines
Zaventem, Flandre, Belgique Parexel Temps pleinWhen our values align, there's no limit to what we can achieve. Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team This is a client dedicated project, and the role can be office or home based in various...
-
Regulatory Affairs Specialist
il y a 4 semaines
Zaventem, Belgique USG Professionals Science Temps pleinUSG Professionals is looking for an Regulatory Affairs Specialist for our client in the region of Zaventem. This can be both as a USG Project Consultant or on a Freelance basis! Functieomschrijving The Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory guidelines and successful execution of regulatory submissions. In...
-
Regulatory Affairs Specialist
il y a 4 semaines
Zaventem, Belgique USG Professionals Science Temps pleinUSG Professionals is looking for an Regulatory Affairs Specialist for our client in the region of Zaventem. This can be both as a USG Project Consultant or on a Freelance basis! Functieomschrijving The Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory guidelines and successful execution of regulatory submissions. In...
-
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...
-
Eu Regulatory Affairs Advisor
il y a 2 semaines
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 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...
