Medtronic

Program Manager – EU MDR & UKCA

Medtronic

full-time

Posted on:

Origin:  • 🇺🇸 United States • Colorado

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Salary

💰 $136,000 - $204,000 per year

Job Level

Mid-LevelSenior

Tech Stack

PMP

About the role

  • Core member of the Post Market Development - Compliance PMO within the Surgical Operating Unit focused on ensuring the Surgical product portfolio achieves initial EU MDR and UKCA
  • Ensure ongoing product safety, efficacy, cost-effectiveness, and market readiness throughout the product lifecycle
  • Collaborate closely across R&D, Regulatory, Quality, Clinical, Operations, Manufacturing, and Supply Chain
  • Shape how the Compliance PMO engages across the Surgical Operating Unit and enterprise; contribute to scalable processes and governance models
  • Develop and monitor schedules, plans, tasks, and priorities; ensure streamlined workflow
  • Drive problem-solving sessions, maintain urgency, and hold team members accountable to commitments
  • Anticipate and mitigate risks, balancing time, schedule, cost, and quality while adhering to safety and regulatory standards
  • Manage project financials, including forecasting and tracking of accruals and actuals
  • Utilize large data sets of interdependent information to create recommendations for action and program success
  • Develop mechanisms for monitoring project progress and intervening for problem solving with cross-functional partners and stakeholders
  • Lead or leverage cross-functional teams to evaluate, develop and manage projects for new product development and ongoing lifecycle management
  • Oversee and manage operational aspects of ongoing projects and serve as liaison between project management, planning, project team, and line management
  • Manage development and implementation processes involving departmental or cross-functional teams focused on delivery of new or existing products and processes
  • Review status of projects and budgets; manage schedules and prepare status reports
  • Monitor projects from initiation through delivery; assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals
  • Gather requirements, perform requirements planning, elicitation and management to meet stakeholder demands
  • Communicate with stakeholders and obtain stakeholder engagement to ensure end products or processes solve business problems

Requirements

  • Bachelors Degree and minimum of 5 years of relevant experience OR advanced degree with a minimum of 3 years of relevant experience
  • 3+ years of experience working with or managing cross-functional teams in a matrixed environment (eg: R&D, Operations, Regulatory, Quality, Marketing)
  • 3+ years leading multiple projects at once of increasing complexity
  • 3+ years of experience with budget management or financial tracking within projects and programs
  • 3+ years leading stakeholder communications across various peer and leadership levels of an organization
  • Knowledge in product development and commercialization in the medical device industry (Nice to Have)
  • PMP or PgMP certification (Nice to Have)
  • Strong knowledge of EU MDR and UKCA regulations (Nice to Have)
  • Experience directly managing or mentoring project managers and/or project coordinators (Nice to Have)
  • Experience with advanced scheduling and resource management tools like Microsoft Project and/or Resource First/PDWare (Nice to Have)
  • Power BI experience and creating data visualizations from large data sets (Nice to Have)