Clinical program manager - ear, nose & throat
The ear, nose and throat (ent) group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomesEnt seeks to improve outcomes for patients suffering from diseases of the ear, nose, and throat by partnering with healthcare providers to deliver market-leading innovative products and solutions to help create better outcomes for more patients.
Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every dayIt’s no accident — we work hard to cultivate a workforce that reflects our patients and partnersWe believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
To learn more about inclusion & diversity at medtronic click here
Preferred location: jacksonville, fl, open for remote.
Travel: 25% domestic travel
Careers that change lives
In this exciting role as a clinical project manager for the eu mdr project, you will primarily focus on coordinating and prioritizing the eu mdr clinical program, including alignment with other key priorities happening concurrently across entThis position will interface with clinical, quality, regulatory, pmo and other cross-functional partners to manage all clinical aspects of the mdd to mdr transition, including executing in concert with business process and procedures, timelines, and evidence generation needs.
This is a dynamic opportunity that will provide exposure to clinical opportunities and cross-functional interactionsProgram decisions are generally made only after consultation with higher-level management.
A day in the life
Collaborate with project team, business units, and workstream/shared services leads, as well as functional leaders from (regulatory, quality, clinical, finance, marketing, r&d and others) to ensure efficient execution of a shared strategy
Partner with mdr enterprise groups and ou leaders regarding common interpretation and guidance, deliverables, pace and progress to ensure a harmonized approach for achieving compliance
Ensure overall compliance; promote creative solutions; ensure on-time completion of individual tasks and project workstream goals
Support the development of harmonized business processes and procedures for execution and compliance with eu mdr
Communicate effectively with program leadership to ensure clear expectations, demonstrate progress and identify issuesProvide progress updates and regular reporting to business and functions leadership
Maintain and track progress and produce applicable reports
Partner with other project leaders to ensure coordination of activities and timelines, facilitating efficient use of resources
Partner with regulatory and quality to align documentation content and strategy
Facilitate regularly scheduled meetings as needed, take meeting minutes with action items, and follow up with smes on expected deliverables.
Work with product teams/smes to develop risk mitigations of project gaps and timelines
Document deliverable completion
Adapt project plans to account for changes in scope or strategy
Assess project issues and develop solutions to meet quality, timing, and budget goals and objectives.
Provide input to establishing program objectives, timelines, milestones, and budgets.
Reviews the work of the team and/or vendors: direct involvement in daily tasks necessary for successful program execution.
Assists with creation and implementation of clinical training as necessary, including cross-functional (in-house) learning of regulation expectations
Supports development and/or re-engineering efforts of local clinical sops and wi in conjunction with medical writing staff
Becomes familiar with medtronic sops and policies, as well as global, country and national regulations as needed to complete projects
Supports audits by regulatory authorities or internal audit teams, as well as corrective and preventative actions, health hazard evaluations, or other quality, regulatory, or clinical improvement initiatives.
All activities must be performed in compliance with the quality system.
Other duties as assigned
Must have: minimum requirements:
In order to be considered for this position, the following must be evident on your resume.
Minimum of 5 years of project management experience in clinical or medical device field,
Or advanced degree with 3 years of project management experience in clinical or medical device field.
Nice to have
Solid understanding of and hands-on experience with meddev and eu mdr
Ability to work in a fast pace, high visibility environment
Strong problem-solving skills; strong team player and work ethic.
Excellent interpersonal, presentation and communication skills
Ability to support multiple projects and balance priorities, work independently or collaboratively to determine and develop solutions
Demonstrated success leading and managing cross-functional teams
Demonstrated success with compliance, remediation, or new product development projects within the medical device industry
Clinical trial experience
Proficiency in microsoft office programs
About medtronic
Together, we can change healthcare worldwideAt medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend lifeWe challenge ourselves and each other to make tomorrow better than yesterdayIt is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our teamLet’s work together to address universal healthcare needs and improve patients’ livesHelp us shape the future.
Physical job requirements
The physical demands described within the responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this jobReasonable accommodations may be made to enable individuals with disabilities to perform the essential functionsFor office roles: while performing the duties of this job, the employee is regularly required to be independently mobileThe employee is also required to interact with a computer, and communicate with peers and co-workersContact your manager or local hr to understand the work conditions and physical requirements that may be specific to each role(ada-united states of america)
A commitment to our employees lives at the core of our valuesWe recognize their contributionsThey share in the success they help to createWe offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Learn more about our benefits: benefits.medtronic.com
This position is eligible for a short-term incentive planLearn more about annual salary and medtronic incentive plan (mip) on page 6 here.
