Project Manager - Medical Devices MDR (m/f/d)

Medical Device Regulation Project Manager

Responsibilities

• Own end‑to‑end delivery for MDR projects, ensuring the portfolio stays on plan (scope, schedule, dependencies, resourcing).
• Drive MDR project execution for Tube Sets for Insufflators, Tube Sets for Pumps, and Devices.
• Coordinate responses and execution for customers’ MDR requests, including impact assessment, planning, and tracking through completion.
• Build and maintain integrated project plans for internal MDR requests (incl. milestones, deliverables, risks, actions).
• Identify, assess, and mitigate project risks, including resource planning, cost reduction opportunities, and contingency actions for technical challenges.
• Ensure disciplined decision‑making, escalation, and transparent reporting.
• Drive cross‑functional collaboration across engineering, supply chain, regulatory, and customers, ensuring alignment with strategic program goals.
• Drive alignment workshops, document review cycles, action tracking, and delivery commitments.
• Identify process improvement opportunities and support adoption of operational excellence tools (PMP, Lean, NGS‑style approaches), coaching teams where needed.
• MDR documentation delivery tracking and readiness reporting.
• Stakeholder communication pack (monthly + ad‑hoc escalations).
• Carry out change procedures to ensure continuous production and monitor dependency to MDR activities.
• Provide clear and consistent communication to leadership and team members, ensuring transparency, accountability, and buy‑in.
• Actively participate in innovation processes and contribute to the development of new solutions in minimally invasive medicine.

Requirements

• 5+ years project management experience in a regulated/technical environment; experience managing multiple parallel projects.
• Strong cross‑functional leadership, structured execution, risk management, and stakeholder communication.
• Experience coordinating document‑heavy deliverables (documentation plans, review cycles, approvals).
• Strong proficiency in project management methodologies and tools (Agile, Waterfall, PMP, Kaizen).
• Knowledge of SAP / Arena PLM is an advantage.
• Strong written and spoken English skills required.
• Willingness to travel to Prelouc, Brno (Czech Republic) and other Novanta locations (up to 20%).

What We Offer

• Versatile tasks in an exciting working environment.
• International teamwork.
• Appreciation and respect.
• Systematic training.
• Room for innovation.
• Career prospects in an expanding company.

Novanta is proud to be an equal‑employment‑opportunity and affirmative‑action workplace. We consider all qualified applicants without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, military and veteran status, disability, genetics, or any other category protected by federal law or Novanta policy.