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Regulatory Affairs Program Manager at Medtronic in Northridge, California

Posted in General Business 30+ days ago.

Type: Full-Time

Job Description:


The Program Manager is responsible for managing aspects of the Multiple Daily Injection Solutions (MDIS) programs. The Multiple Daily Injection Solutions (MDIS) group will focus on defining and executing our full CGM portfolio. Specifically, the initial focus of the Program Manager will be developing global regulatory strategies, preparing U.S. and EU submissions and obtaining approval to introduce new Medtronic products and therapies to markets worldwide.

The Program Manager will translate regulatory requirements into project/product requirements, manage documentation timelines, prepare regulatory submissions, and negotiate their approval with regulatory agencies as required. all while ensuring timely and high-quality execution of assigned regulatory deliverables.

This role focuses on regulatory support for the US, EU, and Global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level at the world's leading medical device company. The Program Manager will work alongside the Sr. RA Manager to provide direction and leadership to a cross-functional team , business group / business unit and regional PMO leaders and representatives, and functional leaders. The position requires the ability to drive strategic activities while also managing tactical activities and communicating 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.

This role has great leadership development opportunities as it operates across the BUs and functions and has the opportunity to influence decision and actions at all leadership levels of Medtronic.

A Day In The Life

  • Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staffs to provide regulatory support for new products.

  • Work with RAS, engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.

  • Prepare FDA submissions and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for market released products.

  • Manages submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, Q-subs, IDEs, export certificates, and establishment registrations and device listings.

  • 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

  • Coordinate with cross-functional teams, including business group / business unit and regional PMO leaders and representatives as well as functional leaders from regulatory, quality and clinical functions to finance, R&D 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

  • Bachelor's degree in Engineering, Business or Science

  • Bachelor's degree and a minimum of 5 years of medical device regulatory experience

  • Advanced degree and a minimum of 3 years of medical device regulatory experience

Nice To Have

  • 5+ years of project and/or people management experience

  • Master's degree in engineering, business or related field

  • PMP Certification or other formal Project Management training and experience

  • Regulatory Affairs Certification (RAC)

  • History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

  • Expertise in IDEs, PMAs, 510(k)s, 180 Days, Design Dossiers, Technical Files,30 day Notices, and Real Time Reviews

  • Experience with regulatory support of clinical trials

  • Knowledge of US and international regulatory requirements including clinical regulations, design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reports. IVD device experience is preferred.

  • Strong track record of leading complex initiatives requiring strong influence management skills and willingness and ability to institute change

  • 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

  • Excellent communication skills and interpersonal/team effectiveness - ability to succinctly and accurately communicate to various levels of management and employees

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

  • Exceptional analytical, planning, organization and time management skills to effectively execute project plans and budgets

  • Clear understanding of the roles and responsibilities of cross- functional project teams and functional management

  • Exceptional program/project management skills; knowledge of process and project planning best practices

  • Business acumen; ability to think from an overall "best for the business" perspective

  • Demonstrates initiative; results oriented

  • Excellent decision making skills - ability to negotiate and balance decisions and manage competing priorities across multiple functional areas

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

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. Let's 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)