SENIOR REGULATORY AFFAIRS PROGRAM MANAGER - strategic program (remote)

The Ear, Nose, and Throat Operating Unit is a global leader and trusted partner for innovative ENT solutions that improve patient access, outcomes, and customer satisfaction. We partner with the ENT community to understand the needs of customers and patients, delivering solutions that improve lives as we embody a culture of accountability and trust.

Over the past 20 years, we have become the global market leader in three key segments - image-guided

surgery, intraoperative nerve monitoring, and powered surgical instruments. We continue to launch valuable ENT solutions in these areas as well as tissue health and balloon sinus dilation.

Careers That Change Lives

The Senior Regulatory Affairs Program Manager is responsible for managing, planning and the integration of Regulatory and Clinical processes and systems at Intersect ENT. ENT's portfolio, consisting of two primary product lines, PROPEL™ and SINUVA™, which are unique bioabsorbable, steroid-eluting (mometasone furoate) drug delivery implants for sinus patients.

The initial responsibilities are merging the processes and system for the combined ENT Operating Unit and will include other programs in the future. The Senior Program Manager will provide direction and leadership to a cross-functional team responsible for integration of Quality Systems. This position requires the ability to drive strategic activities, which includes assessing policy / procedures and developing a robust integration plan. This position will also manage tactical activities and communicate effectively with a functional stakeholders. The Senior 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 .

We are looking for a driven program manager with proven Communication skills and experience in Process Improvement, who is able collaborate with cross functional teams in the field of Regulatory Affairs, Quality, Clinical, and others to meet program milestones, compliance requirements and expectations in terms of quality, costs and time.

You can drive results with your passion to keep teams organized and on-track, as you take them along in your journey of change. You have excellent communication skills and are able to establish trust with the business and your stakeholders. You have experience with leading a project team in a multicultural environment.

A Day In The Life

• 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
• Partner with 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 required
• 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

Nice to Have

• Advanced degree engineering, business or program management
• Experience in the medical industry, ideally the medical device and/or pharmaceutical industry
• Experience with FDA Interpretation, planning, writing/overseeing implementation of processes / quality systems
• 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

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)