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Project Manager - Medical Devices MDR(m/w/x)
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
- English – Native
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
Not a perfect match?
- NovantaFull-timeOn-siteSeniorBerlin
- W.O.M. World of Medicine GmbH
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Project Manager PMO for Medical Devices(m/w/x)
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Senior Project Manager R&D(m/w/x)
Full-timeOn-siteSeniorBerlin
Project Manager - Medical Devices MDR(m/w/x)
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
- English – Native
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
About the Company
Novanta
Industry
Healthcare
Description
The company powers technology products that transform healthcare and advanced manufacturing, enhancing productivity and lives.
Not a perfect match?
- Novanta
Project Manager Medical Devices - MDR(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Project Manager R&D NPI Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Project Manager NPI Product Development Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin - W.O.M. World of Medicine GmbH
Project Manager PMO for Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin - Stryker Berlin GmbH
Senior Project Manager R&D(m/w/x)
Full-timeOn-siteSeniorBerlin