Medtronic

Strategic Technology Program Manager, Regulatory Affairs

Medtronic

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Salary

💰 $120,800 - $181,200 per year

Job Level

Mid-LevelSenior

About the role

  • Business ownership of key regulatory applications facilitating connections between business end users, MCRS, IT, and vendors
  • Project leadership role in the replacement of current RIM solution with a Next Gen RIM system
  • Participate in PDNA as the connection point of Regulatory domain expertise, stakeholder coordination, and technical design considerations in the new PLM platform
  • Contribute to system validation, maintain enterprise configuration and support product release management
  • Vendor relationship management including business input on contracting, financials, audit, and general oversight
  • Identify current & future technology needs to enable functional strategies, including business case development for associated funding asks
  • Advise/evaluate solutions and support selection of vendors, coordinating business input from OU, Regions, and MCRS subject matter experts
  • Lead and/or support pilot and implementation efforts for new software
  • Proactive communication with key stakeholders on systems health, strategy and program execution, including escalation management when required
  • Educating and driving alignment with enterprise standards and consistent utilization of regulatory systems
  • Work onsite a minimum of 4 days a week to support cross-functional collaboration and professional growth

Requirements

  • Bachelor’s degree plus 5+ years of direct Regulatory Affairs experience within the medical device or other regulated industry (or 3+ years with an advanced degree)
  • Direct Regulatory Affairs experience within medical device or other regulated industry
  • Strong regulatory domain expertise
  • Deep understanding of Regulatory Affairs processes, including regulatory information management (RIM) systems
  • Proven experience leading large-scale technology implementation projects, including system replacement efforts and cross-functional stakeholder coordination
  • Experience managing vendor relationships, including contracting, financial oversight, and audits
  • Skilled in identifying future technology needs, evaluating solutions, and developing business cases
  • Hands-on experience with system validation, pilot testing, and implementation of new software
  • Experience with core regulatory systems (e.g. Calyx RIM, RAD D2, Insight DX, GTS) (Nice to Have)
  • Ability to navigate complex organizational structures and foster collaboration across business units, IT teams, and external vendors
  • Strong collaboration, negotiation, strategic planning, and problem-solving skills
  • Willingness to be onsite a minimum of 4 days a week