1+ months

Sr Reg Affairs Program Manager

Medtronic
Northridge, CA 91325
Sr Reg Affairs Program Manager

Location:

Northridge, California, United States

Requisition #:

210006DC

Post Date:

Mar 04, 2021


**SENIOR REGULATORY AFFAIRS PROGRAM MANAGER - EU MDR (Diabetes)**


The Diabetes Operating Unitfocuses on improving the lives of those within the global diabetes community.As a business, we strive to empower people with diabetes to live life on their terms by delivering innovation that truly matters and providing support in the ways they need it. Were committed to meeting people with diabetes where they are in their journey, always with an aim to make theirlives easier. Our portfolio of innovative solutions are designed to provide customers greater freedom and better health, helping them achieve better glucose control, while spending less time managing their disease.


Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.


**Careers That Change Lives**


The **Senior Regulatory Affairs Program Manager i** s responsible for managing aspects of regulatory programs to achieve compliance. Specifically, the initial focus will be managing dependencies across the workstreams and assessing program opportunities for the EU Medical Device Regulation (EU MDR) but may include other programs in the future. The Program Manager will provide direction and leadership to a cross-functional team responsible for implementation of EU MDR. This position requires the ability to drive strategic activities, which includes developing a robust risk mitigation plan. This position will also manage tactical activities and communicate effectively with a large group of stakeholders. The Program Manager is responsible for ensuring team commitments (scope, schedule and budget) are met and communicated in a timely manner, and risk mitigations are implemented .


This role has great leadership development opportunities.


**A Day In The Life**


+ Work within established EU MDR governance models and identify, recommend and drive execution of approved process improvement initiatives to promote efficiencies

+ Document program deliverables, including project plan

+ Develop, plan, communicate and deploy program schedules, activities to ensure timely completion

+ Initiate and monitor progress of activities necessary for compliance against project phases and milestones

+ Lead program execution to enable results and maintain commitments, including escalation to management for resolution of non-standard solutions

+ Responsible for milestone and objective planning, establishing daily tasks necessary for successful program execution and driving progress

+ Define and report metrics (scorecards) on program progress, implementation and effectiveness; deliver management reporting and escalation when required

+ Coordinate with cross-functional teams, including business unit representatives as well as functional leaders from regulatory, quality and clinical functions to finance, RD and operations

+ Partner with EU MDR Subject Matter Expert(s) regarding common Medtronic interpretation and guidance, deliverables, pace and progress across the organization to ensure a harmonized approach for achieving compliance


**Must Have; Minimum Requirements**


+ Bachelors degree in Engineering, Business or Science

+ Minimum 7 years of Program Manager experience in a regulated environment including broad multi-functional business experience

+ OR advanced degree and a minimum of 5 years of Program Manager experience in a regulated environment including broad multi-functional business experience


**Nice To Have**


+ Masters degree in engineering, business or related field

+ Experience in the medical industry, ideally the medical device or pharmaceutical industry

+ PMP Certification or other formal Project Management training and experience

+ General knowledge of Regulatory Affairs, Clinical, Quality Management Systems and compliance requirements for medical devices

+ Project leadership/change management experience

+ Experience managing global initiatives

+ Experience driving change management initiatives across an organization

+ Experience with MS Project, MS Excel, MS PowerPoint and MS Word

+ Demonstrated leadership for business process harmonization across an organization

+ Experience implementing initiatives through effective influence management skills at multiple levels in the organization

+ Prior consulting experience

+ Experience in creating and delivering presentations to senior leadership

+ Excellent facilitation and issue resolution skills

+ Previous experience managing in a matrix organization

+ Experience providing work direction and leadership to people and teams in a management role

+ Strong influence management skills; ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals

+ Demonstrated capacity for strategic thinking, project planning and project management


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It 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 team. Lets work together to address universal healthcare needs and improve patients lives. Help 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 job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact 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 values. We recognize their contributions. They share in the success they help to create. We 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 plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2021-03-09 Expires: 2021-05-15

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Sr Reg Affairs Program Manager

Medtronic
Northridge, CA 91325

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