Project Manager (Medical Devices MDR)

TL;DR

Project Manager (Medical Devices MDR): Leading cross-functional teams to deliver MDR-related project outcomes for medical device portfolios with an accent on technical documentation, risk management, and regulatory compliance. Focus on driving project execution, coordinating stakeholders, and ensuring alignment with strategic program goals in a regulated environment.

Location: Berlin, Germany (Onsite)

Company

hirify.global is a global leader in engineered components and sub-systems for mission-critical applications in healthcare and advanced manufacturing.

What you will do

• Own end-to-end delivery for MDR projects, ensuring scope, schedule, and resourcing remain on plan.
• Coordinate responses and execution for customer MDR requests, including impact assessment and tracking.
• Build and maintain integrated project plans, including milestones, deliverables, and risk mitigation strategies.
• Drive cross-functional collaboration across engineering, supply chain, and regulatory departments.
• Ensure disciplined decision-making, escalation, and transparent reporting to leadership.
• Identify process improvement opportunities and support the adoption of operational excellence tools.

Requirements

• 5+ years of project management experience in a regulated or technical environment.
• Strong proficiency in project management methodologies such as Agile, Waterfall, or PMP.
• Proven experience coordinating document-heavy deliverables and review cycles.
• Strong written and spoken English skills.
• Willingness to travel up to 20% to other company locations.

Nice to have

• Knowledge of SAP or Arena PLM systems.
• Experience with Kaizen or Lean methodologies.

Culture & Benefits

• Opportunity to work in an expanding international company.
• Support for systematic training and professional development.
• Collaborative and empowering team culture.
• Focus on innovation in the field of minimally invasive medicine.