Novanta
Project Manager - Medical Devices MDR(m/w/x)
Full-timeOn-siteSenior
Berlin
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NONovanta
Project Manager Medical Devices - MDR(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
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
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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NONovanta
Project Manager Medical Devices - MDR(m/w/x)
Berlin
Full-timeOn-siteSenior
Nejo AI Summary
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
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.
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
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
Senior Systems Engineer Medical Devices(m/w/x)
Full-timeOn-siteSeniorBerlin - Stryker Berlin GmbH
Senior Project Manager R&D(m/w/x)
Full-timeOn-siteSeniorBerlin