Job Description

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

Job Tags

Hourly pay, Full time, Work experience placement, Internship, Seasonal work, Local area, Remote job,

Similar Jobs