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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
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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
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
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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