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Regulatory Affairs Project Manager
Il y a 3 mois
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.
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 EnglishThorough knowledge and understanding of the medical device industry and regulatory environmentStrong and in-depth knowledge of Project Management, Transformation Management, SAP, BPO and Agile or Lean Sigma methodologiesExperience in leading, managing and implementing integration programmes/projectsAbility 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 situationExtra net allowance €80 per month, on top of your net salaryMileage allowance or option for company car (subject to conditions)Meal vouchers worth €140 for 20 days workedEco cheques of €250 per yearHoliday pay and 13th month12 extra holidays per yearHospitalisation insurance with DKVPension savings We also offer numerous training courses, fun activities, advancement opportunities, ... to guide you through your career.
