Medtronic Senior Program Manager, Regulatory Affairs in Minnesota
Senior Program Manager, Regulatory Affairs
Minnesota, United States
Apr 02, 2021
SENIOR PROGRAM MANAGER, REGULATORY AFFAIRS
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.
Preference is for this position to be based inMinnesota, though a remote assignment will be considered.
Careers That Change Lives
The Senior Program Manager, Regulatory Affairs will be the primary Regulatory leader for Medtronic in support of Global Sterilization Transformation. They will be responsible for driving enterprise-wide Regulatory strategy alignment, leading the Global Regulatory Workstream, and influencing key decision makers across Medtronic to deliver harmonized One Medtronic regulatory submissions for sterilization. This role will coordinate and lead critical regulatory agency partnership collaboration in order to influence new regulatory guidelines and/or policymaking for industry-wide Sterilization of Medical Devices.
A Day In The Life
Lead the Global Sterilization Regulatory Workstream to deliver transformation of sterilization across the enterprise
Coordinate and lead partnerships and collaboration sessions with regulatory agencies to influence new regulations and policymaking for sterilization of Medical Devices
Partner with Medtronic-wide regulatory and technical leaders across all regions to collaborate and define submission strategy
Accountable for the development and creation of regulatory strategies to ensure Sterilization Transformation goals are met for Ethylene Oxide Cycle Optimization, Network Optimization, and Modern Sterilization Technology Development
Manage the preparation of Medtronic optimized sterilization submissions for FDA and global regulatory agencies; drive collaboration across business units for projects impacting multiple sites, businesses, and product families.
Accountable for FDA and global regulatory body engagement and alignment with modern sterilization technology test methods and validation strategy
Must Have: Minimum Requirements
Bachelors degree required
Minimum of 7 years of regulatory affairs experience in medical device or pharmacuetical manufacturing,
Or advanced degree with a minimum of 5 years regulatory affairs experience inmedical device or pharmacuetical manufacturing
Nice To Have
Sterilization or Microbiology background
Familiarity and experience with regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices
Exceptional emotional stability, problem solving skills, written communications skills.
Computer proficiency using remote collaboration tools such as OneNote, sharepoint online, or shared file editing software.
Demonstrated ability to understand and apply advanced scientific principles.
Must be able to handle multiple projects and effectively manage priorities with stakeholders.
Demonstrated ability to thrive in a team environment, including cross-functional teams, and exert influence without alienating others.
Demonstrated stakeholder influencing and creative solution design for complex problems.
Excellent organizational skills.
Excellent communication and presentation skills; ability to update and influence senior executive leadership
Strong written, verbal communication skills.
Results oriented and successful in driving accountability through influence of cross functional team members without direct authority
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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