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NONovanta

Project Manager - Medical Devices MDR(m/w/x)

Berlin
Full-timeOn-siteSenior

Leading cross-functional teams for MDR projects in minimally invasive medical devices. 5+ years project management experience in regulated environments required. International teamwork, systematic training.

Requirements

  • 5+ years project management experience in regulated/technical environment
  • Experience managing multiple parallel projects
  • Strong cross-functional leadership
  • Structured execution
  • Risk management skills
  • Stakeholder communication skills
  • Experience coordinating document-heavy deliverables
  • Strong proficiency in project management methodologies
  • Strong proficiency in project management tools
  • SAP knowledge is an advantage
  • Arena PLM knowledge is an advantage
  • Strong written English skills
  • Strong spoken English skills
  • Willingness to travel up to 20%
  • Excellent communication skills
  • Excellent stakeholder management skills
  • Excellent problem-solving skills
  • Ability to inspire confidence
  • Ability to manage change
  • High level of empathy
  • High level of emotional intelligence
  • Ability to secure team buy-in
  • Analytical mindset
  • Attention to detail
  • Ability to manage complexity
  • Proactive attitude
  • Accountability
  • Results-oriented mindset
  • Global mindset
  • Drive for success

Tasks

  • Lead cross-functional teams for MDR projects
  • Deliver MDR-related project outcomes across portfolio
  • Drive planning and execution of technical documentation
  • Manage project risks proactively
  • Coordinate internal and external contributors
  • Ensure alignment with document plans and submission readiness
  • Own end-to-end MDR project delivery
  • Maintain project scope, schedule, dependencies, and resourcing
  • Execute MDR projects for Tube Sets for Insufflators
  • Execute MDR projects for Tube Sets for Pumps
  • Execute MDR projects for Devices
  • Coordinate responses to Customers’ MDR requests
  • Assess impact of MDR requests
  • Plan and track MDR request completion
  • Build integrated project plans for internal MDR requests
  • Identify and assess project risks
  • Mitigate resource planning and cost reduction challenges
  • Develop contingency actions for technical issues
  • Ensure disciplined decision-making and escalation
  • Provide transparent project reporting
  • Drive cross-functional collaboration
  • Align with strategic program goals
  • Conduct alignment workshops
  • Review and track document cycles
  • Ensure delivery commitments
  • Identify process improvement opportunities
  • Support adoption of operational excellence tools
  • Coach teams in PMP/Lean/NGS approaches
  • Track MDR documentation delivery
  • Report MDR readiness
  • Prepare stakeholder communication packs
  • Handle monthly and ad-hoc escalations
  • Implement change procedures for continuous production
  • Monitor MDR activity dependencies
  • Communicate clearly to leadership and team members
  • Ensure transparency and accountability
  • Participate in innovation processes
  • Contribute to new solutions in minimally invasive medicine

Work Experience

  • 5 years

Education

  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishNative

Tools & Technologies

  • Agile
  • Waterfall
  • PMP
  • Kaizen
  • SAP
  • Arena PLM

Benefits

Diverse Work

  • Versatile tasks
  • Exciting working environment

Informal Culture

  • International teamwork
  • Appreciation and respect

Learning & Development

  • Systematic training

Startup Environment

  • Room for innovation

Career Advancement

  • Career prospects
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Novanta and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.

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