Medtronic Associate Regulatory Operations Specialist in Minneapolis, Minnesota
Associate Regulatory Operations Specialist
Minneapolis, Minnesota, United States
Jan 11, 2021
ASSOCIATE REGULATORY OPERATIONS SPECIALIST
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
This position is part of the Coronary and Structural Heart (CSH )Shared Services Regulatory Operations Group. As an Associate Regulatory Operations Specialist you will support regulatory submission development and regulatory processes. Primary responsibilities include assisting in the preparation, publication, quality control and delivery of paper and electronic regulatory submissions, as well as working with Geography RA groups to complete product registrations and providing notification of changes. Submissions are produced with electronic publishing tools in compliance with internal and external document standards. Prepares, submits, tracks, indexes and archives electronic submissions, as well as related information including approvals, amendments, annual reports, and FDA/Regulatory Agency communications. Additional duties include developing international device product registrations, maintaining global product registrations, and developing department processes and systems. Primarily interfaces with regulatory affairs teams, project leaders, and manager.
A Day In The Life
Ensure submissions are produced with electronic publishing tools in compliance with document management standards.
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs.
Ensures continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors.
Prepares, submits, tracks, indexes and archives electronic submissions including information, amendments, annual reports, general correspondence, adverse event reporting, and promotional materials.
Responsible for helping to develop and to manage international product registrations, including working with the CSH regulatory affairs team and OUS geography specialists to respond to requests for information.
Basic understanding of global regulatory requirements and approach for researching detailed requirements.
Responsible for participating in lean sigma/A3 DMAIC projects within the department to improve processes. This includes identifying and implementing metrics to enhance business efficiencies.
Must Have: Minimum Requirements
0 years of experience
Nice to Have
Experience in medical device
Experience with regulatory affairs or quality
Intermediate knowledge of Word, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, SharePoint, and Sitebuilder).
Organizational skills, highly detail oriented, and effective project management skills.
Flexible with changing priorities, self-motivated, strong work ethic, attention to detail, works well under pressure in a dynamic environment.
Exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral)
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)
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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