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

Build a career powered by innovations that matter!  At Novanta, our innovations power technology products that are transforming healthcare and advanced manufacturing—improving productivity, enhancing people’s lives and redefining what’s possible.  We create for our global customers engineered components and sub-systems that deliver extreme precision and performance for a range of mission-critical applications—from minimally invasive surgery to robotics to 3D metal printing.

Novanta is one global team with over 26 offices located in The Americas, Europe and Asia-Pacific.  Looking for a great place to work?  You have found it with a culture that embraces teamwork, collaboration and empowerment.  Come explore Novanta.

This position is part of Novanta’s Advanced Surgery (AS) business unit. Specialized in the field of Minimally Invasive Medicine, Novanta develops devices and accessories so that doctors can operate with small cuts. We produce Cameras, Insufflators, Medical Pumps, and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers, doctors, and technical experts, our teams continuously search for new ways to innovate.

As Medical Device Regulation Project Manager, you will lead cross-functional teams to deliver MDR-related project outcomes across the portfolio (Tube Sets, Pumps, Devices, Insufflators). You will drive planning, execution, and timely completion of technical documentation deliverables, proactively manage risks, coordinate internal and external contributors, and ensure alignment to agreed document plans and submission readiness.

What we offer you:

Versatile tasks in an exciting working environment

International teamwork

Appreciation and respect

Further Systematic training

Room for innovation

Career prospects in an expanding company

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
  • 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 stakeholders/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)
• Carrying 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)
• SAP / Arena PLM knowledge 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 %)

Personal profile:

• Excellent communication, stakeholder management, and problem-solving skills; ability to inspire confidence and manage change
• High level of empathy, emotional intelligence, and ability to secure team buy-in.
• Analytical mindset with attention to detail and ability to manage complexity
• Proactive, accountable, and results-oriented, with a global mindset and drive for success

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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.

Please call +1 781-266-5700 if you need a disability accommodation for any part of the employment process.