Overview
Skills
Job Details
Hello;
Senior Project Manager with Work Experience in Medtronics, PLM and Regulatory Experience
Job location:- Remote
Long Term
Note from the client:- Candidate should worked with Medtronics Previously and has PLM and Regulatory Experience
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
As the Sr. Project Manager, you will lead the Regulatory Workstream
Serve as functional and process owner for workstream driving the day to day activities.
Lead requirement gathering and business process design.
Establish the data flow and a design that maximises individual and organizational efficiency.
Lead the Regulatory Strategy Meeting and develop close working relationships with the Regulatory leadership team.
Integrate the Product-DNA plans with those being developed by the Regulatory team.
Monitor scope inter-dependencies with other workstreams or governed projects.
Responsible for workstream performance, risk management, and issue resolution.
Develop and monitor KPIs, scope, spend, savings and return on investment targets.
Lead and/or participate on teams to structure issues, perform analyses, evaluate options, and develop recommendations on key process and system questions.
Identify and engage necessary functional and group-specific SME's.
Work with SMEs / OCM on stakeholder management, business process definition, change impacts and training.
Define acceptance criteria, develop test scripts for Usability Pilots and User Acceptance Testing.
Monitor progress at defined points to ensure work is delivered on time, within budget and meets or exceeds expectations
Collaborate with solution architects to determine development sequencing.
Participate in release planning, sprint/iteration planning and demos.
Participate in feature integration, testing, verifying delivered user stories against sprint/increment goals.
Champion Product DNA in a way that engages and excites the end user community.
Must Have: Minimum Requirements
Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
Nice to Have
o 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