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Originele vacaturetekst

Regulatory Affairs Program Manager

Careers that Change Lives

At our Bakken Research Center in Maastricht, about 400 clinical researchers, scientists and technical engineers cooperate closely with medical specialists in and outside of Europe to develop new and improve existing therapies.

Our services include centralized regulatory support and advice for CE marking in Europe, for clinical studies and clinical data needs, and for product registrations in the EMEA region.

A Day in the Life

  • Ensures the Regulatory Affairs management strategy is transformed into relevant regulatory and quality strategies in the RA EMEA pre-market organization.
  • Organize and lead cross-functional project teams. Support and drive regional projects and continuous improvement activities in line with business objectives.
  • Actively promote, support and (help) deploy Medtronic Operating System within and act as OpEx contact person on behalf of the department.
  • The role is a member of the RA EMEA pre-market management team
  • Lead/ coach/ challenge functional groups/ cross-functional project teams to meet goals and commitments (related to key strategic/ operational excellence initiatives)
  • Provide critical leadership to ensure overall quality of project planning, execution and outcome, while minimizing and mitigating project/ business risks through (overseeing the) development, coordination and monitoring of:
  • Strategic project plans (including schedules, budgets and resources)
  • Risk management plans/ escalation paths
  • Change management plans
  • Define project resource requirements and negotiate team assignments with functional managers
  • Provide routine project/ program status communication to sponsors/ stakeholders/ steering committees
  • Support leadership team in shaping departmental vision, defining strategic roadmaps, setting organizational targets & objectives and corresponding AOP/ budgeting needs
Must Haves

Bachelor’s / Master’s degree
Completed Project Management Professional (or equivalent) training (certification)
Lean Sigma Black Belt training (certification)
Knowledge of process and project planning best practices
Knowledge of standards, directives and regulations related to the department’s scope of work (e.g. ISO:13485, ISO:14971, MEDDEV, EU MDR(2017), EU GDPR)
Business/ financial acumen: ability to think from an overall “best for the business” perspective
Decision making: ability to negotiate and balance decisions and priorities across needs of several functional areas/ departments
Customer focused: ability to understand customer requirements and incorporate into business decisions
Dynamic, pro-active, positive attitude, data driven, result oriented

7+ years of project and/ or people management experience
5+ years of relevant work experience in a broad, multi-functional business environment, preferably in Medical Device/ Pharmaceutical industry
Practical program management experience, working with changing business priorities and the ability to juggle multiple initiatives with high visibility and/ or short delivery windows
Demonstrated ability to:
exercise independent judgement or initiative
interface with and influence opinions of senior (executive) leadership
succinctly and accurately communicate to various levels of management/ employees
build effective relationships across functions/ organizations/ geographies
manage the activities of one or more medium (large) scale projects simultaneously
Proficient in the use of Project/ Program Management tools and the application of continuous improvement methodologies (such as lean 6 sigma)
Proven capacity for strategic thinking, project planning & management
Strong interpersonal skills/ leadership capabilities: building, motivating, coaching and directing (cross-functional) teams/ team members to meet project objectives
Strong business case development skills with good cost accounting vocabulary
Excellent written, verbal and presentation skills (business English)
Computer literate (MS Office suite, databases/ browsers, data mining/ analysis and communication tools)
Communicates well and fluent in English, both in writing and speaking.
Some (inter)national travel (<10%) is part of the job.

We Offer

In our 5th Tenet of our Mission we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.
Also a competitive package is of course part of that. We offer a competitive salary and benefits package to all our employees:

· 31 holidays;

· Possibility to purchase 8 extra vacation days;

· Flexible working environment;

· Annual Incentive Plan % depending on company results;

· Pensionscheme and group discount on healthcare insurances

· Tax advantages on commuting, fitness plan

- A company lease car is assigned to this role.

· Training possibilities via Cornerstone/Harvard Manage Monitor/GetAbstract

· Employee Assistance Program and Recognize! (our global recognition program)

Your Answer

Is this the position you were waiting for? Then please apply directly via the apply button!

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.

We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.

Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

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