Regulatory Affairs Project Manager
il y a 3 semaines
Are 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 to drive efficient processes and achieve project milestones. 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.
You can fill this role via Randstad Professionals - Life Sciences Vlaanderen either as a consultant or freelancer.
key 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.
qualifications
o 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.
key benefits
We serve you a contract as an employee or freelancer and an interesting assignment.
Your salary is complemented by a package of interesting conditions:
Extra net allowance €80 per month, on top of your net salaryMeal vouchers worth €140 for 20 days workedEco vouchers worth €250 per yearHoliday pay and 13th month12 extra holidays per yearHospitalisation insurance with DKVPension savings We look forward to welcoming you to the team.-
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