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Project Manager Medical Devices - MDR(m/w/x)
End-to-end delivery of technical documentation and submission readiness for medical tube sets and pumps. Minimum 5 years of project management experience in regulated environments required. Cross-functional leadership of parallel MDR projects in a global sub-system manufacturing context.
Requirements
- 5+ years project management experience
- Experience managing multiple parallel projects
- Strong cross-functional leadership
- Structured execution and risk management
- Effective stakeholder communication
- Experience coordinating document-heavy deliverables
- Proficiency in project management methodologies
- SAP or Arena PLM knowledge
- Strong written and spoken English
- Willingness to travel up to 20%
- Excellent communication and problem-solving skills
- Ability to manage change
- High empathy and emotional intelligence
- Analytical mindset and attention detail
- Proactive, accountable, and results-oriented
Tasks
- Lead cross-functional teams for MDR projects
- Manage portfolio outcomes for tube sets, pumps, and devices
- Drive planning and execution of technical documentation
- Ensure submission readiness and document plan alignment
- Own end-to-end delivery of MDR project scope and schedules
- Manage project dependencies and resource allocation
- Coordinate responses to customer MDR requests
- Perform impact assessments and track request completion
- Build integrated project plans with milestones and risks
- Identify and mitigate technical and financial project risks
- Implement contingency actions for technical challenges
- Ensure disciplined decision-making and transparent reporting
- Facilitate collaboration between engineering, supply chain, and regulatory
- Align project activities with strategic program goals
- Drive alignment workshops and document review cycles
- Track actions and delivery commitments
- Identify process improvements and operational excellence opportunities
- Coach teams on PMP and Lean methodologies
- Track MDR documentation delivery and readiness
- Prepare monthly stakeholder communication and escalation packs
- Execute change procedures to ensure continuous production
- Monitor production dependencies related to MDR activities
- Provide transparent communication to leadership and teams
- Participate in innovation for minimally invasive medicine solutions
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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
Other Benefits
- Disability accommodation
Not a perfect match?
- W.O.M. World of Medicine GmbHFull-timeOn-siteSeniorBerlin
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Project Manager Medical Devices - MDR(m/w/x)
End-to-end delivery of technical documentation and submission readiness for medical tube sets and pumps. Minimum 5 years of project management experience in regulated environments required. Cross-functional leadership of parallel MDR projects in a global sub-system manufacturing context.
Requirements
- 5+ years project management experience
- Experience managing multiple parallel projects
- Strong cross-functional leadership
- Structured execution and risk management
- Effective stakeholder communication
- Experience coordinating document-heavy deliverables
- Proficiency in project management methodologies
- SAP or Arena PLM knowledge
- Strong written and spoken English
- Willingness to travel up to 20%
- Excellent communication and problem-solving skills
- Ability to manage change
- High empathy and emotional intelligence
- Analytical mindset and attention detail
- Proactive, accountable, and results-oriented
Tasks
- Lead cross-functional teams for MDR projects
- Manage portfolio outcomes for tube sets, pumps, and devices
- Drive planning and execution of technical documentation
- Ensure submission readiness and document plan alignment
- Own end-to-end delivery of MDR project scope and schedules
- Manage project dependencies and resource allocation
- Coordinate responses to customer MDR requests
- Perform impact assessments and track request completion
- Build integrated project plans with milestones and risks
- Identify and mitigate technical and financial project risks
- Implement contingency actions for technical challenges
- Ensure disciplined decision-making and transparent reporting
- Facilitate collaboration between engineering, supply chain, and regulatory
- Align project activities with strategic program goals
- Drive alignment workshops and document review cycles
- Track actions and delivery commitments
- Identify process improvements and operational excellence opportunities
- Coach teams on PMP and Lean methodologies
- Track MDR documentation delivery and readiness
- Prepare monthly stakeholder communication and escalation packs
- Execute change procedures to ensure continuous production
- Monitor production dependencies related to MDR activities
- Provide transparent communication to leadership and teams
- Participate in innovation for minimally invasive medicine solutions
Work Experience
- 5 years
Education
- Bachelor's degreeOR
- Master's degree
Languages
- English – Business Fluent
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
Other Benefits
- Disability accommodation
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?
- 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
Senior Systems Engineer Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin - W.O.M. World of Medicine GmbH
Project Manager PMO for Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin - Novanta Group Europe GmbH
Product Manager Medical Devices(m/w/x)
Full-timeOn-siteExperiencedBerlin