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.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 environmentInternational teamworkAppreciation and respectFurther Systematic trainingRoom for innovationCareer 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#LI-UK1#BerlinNovanta 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 if you need a disability accommodation for any part of the employment process.**Solving complex challenges, delivering innovations that matter!** is a leading global supplier of core technology solutions that give medical, life science, and advanced industrial original equipment manufacturers a competitive advantage. We combine deep proprietary expertise and competencies in precision medicine, precision manufacturing, robotics and automation, and advanced surgery with a proven ability to solve complex technical challenges. This enables Novanta to engineer proprietary technology solutions that deliver extreme precision and performance, tailored to our customers' demanding applications. The driving force behind our growth is the team of innovative professionals who share a commitment to innovation, the Novanta Growth System, and our customers’ success. Novanta’s common shares are quoted on Nasdaq under the ticker symbol "NOVT".
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