Overview
Skills
Job Details
Role: Senior Project Manager
location: Remote
Duration: 12+ Month
Level | Skill | Core Concepts |
Expert | Product Lifecycle Management (PLM) Systems | Windchill, Teamcenter, Change Management, Product Data Management, Configuration Control |
Expert | Medtech Regulatory Compliance Knowledge | FDA 510K, PMA, UDI, CE mark, EU MDR, GxP, FURLS, BUDI |
Expert | Stakeholder Management and Influence | Cross-functional influence, Stakeholder mapping, SME engagement, Interpersonal diplomacy |
Proficient | Cross-OUs Regulatory Process Navigation | Medtronic OUs, OU-specific compliance variance, Inter-OU collaboration |
Proficient | Regulatory Strategy and Workstream Ownership | Strategic planning, Business process modeling, Scope-risk interdependencies, ROI tracking |
Proficient | Change Management | OCM, Stakeholder readiness, Training planning, Resistance management |
Competent | Agile Program Delivery and Testing | Scrum, Sprint Planning, User Acceptance Testing, Test script development |
Competent | KPI and Performance Monitoring | Performance metrics, ROI, Cost-benefit analysis, Workstream evaluation |
Please find the below Notes from the Client
Ensure candidates are technically strong + interpersonal rockstars
Technical & Domain Experience
Strong PLM (Product Lifecycle Management) expertise
Deep knowledge of Medtronic-specific processes and regulatory landscape (especially medtech and FDA/GxP compliance)
Familiarity with engineering and regulatory operations across different Medtronic Operating Units (OUs)
Soft Skills (High Priority)
Bridge-building & interpersonal communication: Must work across OUs with teams that have different regulatory processes and resist change
Ability to facilitate agreement across diverse stakeholders with different viewpoints
Exceptional listening and diplomacy skills to manage experienced SME teams
Strategic Role Characteristics
Ability to gain trust and drive consensus in a complex, change-resistant environment
Comfortable with both high-level strategic discussions and deep technical/regulatory details
Value in someone who is not just technically capable but a true influencer and integrator
Job Description:
- Bachelor s degree and a minimum of 9+ years of relevant experience including broad multi-functional business experience along with 5+ years of project and/or people management experience, or - Master s degree and a minimum of 5 years of relevant experience including broad multi-functional business experience along with 3-5 years of project and/or people management experience.
- Solid program manager experience with a drive for continuous improvement and a passion to be a change agent.
- Strong leadership skills with proven record of managing successful projects/teams.
- Experience implementing initiatives through effective influence management skills at multiple levels in the organization.
- Must be comfortable with ambiguity, adept at change management, and capable of working in cross functional teams.
- Excellent facilitation and issue resolution skills.
- Experience leading efforts in an FDA/ISO regulated environment. - Familiarity with regulatory submissions (e.g. Q, 510K, PMA, UDI, FURLS, CE mark, BUDI, etc.) to governing bodies such as FDA, EU, Korea, China, etc., their local notified bodies and regulatory agencies.
- Familiarity with the evolving regulatory landscape and how that needs to influence the data model attributes related to regulatory submission and device registration as well as the progression from manual submission towards automated submission between medical device companies and regulatory bodies.
- Familiar with the connection between regulatory submissions needed with respect to product changes requiring updated GTS licensing.
- Experience with medical device product development to ensure that regulatory issues are addressed as an integral part of the enterprise change control process.
- Knowledge and understanding of EU MDR requirements.