Project Manager (m/f) Cross-Enterprise EU Medical Device Regulation Implementation

Job TitleProject Manager (m/f) Cross-Enterprise EU Medical Device Regulation Implementation

Job Description

Project Manager (m/f) Cross-Enterprise EU Medical Device Regulation Implementation

Location: EU-based remote employee preferably Netherlands or Germany.

Your challenge

Your challenge as a project manager in the European Union Medical Device / In-Vitro-Diagnostic Regulation (EU MDR / IVDR) Program Management Office (PMO) is to support the cross-enterprise framework design that ensures compliance in:

  • Pre-market
  • Distribution
  • Post-market surveillance
  • Product portfolio compliance

This involves confidence & diligence in supporting efforts that directly enable us to achieve timely EU MDR / IVDR milestone completion and ultimately overall compliance by the May 2020 and May 2022 deadlines.

Responsibilities

Working in the medical industry offers unique fulfillment in supporting product and service offerings that offer great value to prevention, diagnosis, and treatment of patients worldwide. As part of our HealthTech – focused company, you will support the EU MDR / IVDR program with coordination, project and task planning, risk analysis/mitigation, analytics & reporting, and effective meeting planning & execution. While this program is based in Philips HQ [Strategic Value Added Layer (SVAL)], our work links to all Philips business entities and includes pre-market, distribution, post-market, and enabling IT system functions.

Key areas of responsibilities (KARS) for this role include:

Support the EU MDR / IVDR program management office to effectively & methodically execute:

  • Project planning & management: Support timeline development, review, and revision, including critical milestone identification.
  • Tools & references: Responsible for effective organization of program tools & references.
  • Maintains tools needed for effective program execution such as action item trackers, timelines (in PowerPoint, Excel, and / or MS Project), etc.
  • May include management of Sharepoint interface, structure, and relevance (internal and external-facing content).
  • Decision Support / Key Performance Indicators: Supports:
  • Developing, managing tracking, and collecting Key Performance Indicators (KPIs).
  • Review and feedback to the submitting stakeholder.
  • Analytics revision across all KPIs.
  • Key meeting preparation / execution / follow-up: May support development of objectives, agendas, content, and summaries for key program and sr. management meetings, as well as effective follow-up and action item closure.
  • Stakeholder coordination:
  • Supports, as assigned, specific stakeholder coordination activities to ensure diligent coordination, issue resolution, and continuous improvement with the extensive stakeholder community of the EU MDR / IVDR program.
  • Promotes consistency and alignment with cross-Business Group / Business Unit project planning / execution with peer project managers.
  • Governance support:
  • May monitor governance recommendations and decisions, ensuring appropriate follow-through.
  • Provides internal PMO feedback on structural issues in processes / approaches to SVAL / process-department owners and support effective improvement steps.
  • Communications: May support internal program and external Philips communication, which includes content and planning for communications cascades, and supporting review / feedback.

Your team

You are part of the Philips Global Regulations & Standards (GR&S) team, which is critical to interpret, influence, and apply worldwide regulations and standards to Philips Health Tech. Our team's members are located in the US, EU, and Asia to execute this vital responsibility.

The role reports solid line to the EU MDR / IVDR program director within GR&S.

We are looking for:

A person who is excited by the unique professional challenges that a large scale, cross-functional, cross-enterprise transformational program offers in the medical technology industry. The individual should have some technical competency, and demonstrates resilience in challenging situations. We are looking for a diligent, self-starter who can distill complexity into logical actionable steps and communicate this clearly in both written documents and in meeting environments. We're looking for someone who is energetic and encourages others to adopt a 'can-do' mentality in our relentless pursuit to improve the quality of life for the billions of people the Philips brand touches each year.

Specific requirements for this position include:

  • A bachelor's degree, preferably in a life sciences or engineering discipline.
  • A minimum of 5 years of life sciences or related work experience.
  • Experience in project management required.
  • Exposure to Lean / DMAIC / 6-Sigma methodologies preferred.
  • Written & spoken English language fluency required with functional capability in a second language desirable.
  • Ability and willingness to travel both domestically and internationally up to 25% of the time.

Our offer

This role comes with a competitive compensation offering and holiday / vacation offering. Quality & Regulatory are at the top of Philips leadership agenda and that means you have the unique opportunity to join us and have an exciting opportunity to be a part of transformational change. And when you are successful in this role's mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and / or geographies.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.

Contact

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