What are the responsibilities and job description for the Associate Regulatory Operations Specialist (USA/Remote) position at Medtronic?
This position is part of the Global Regulatory Operations Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization, supporting regulatory systems and processes. Primary responsibilities include supporting our Unique Device Identification (UDI) system and teams to ensure data integrity in our regulated systems such as the Global Unique Device Identification Database (GUDID). Duties may include data entry, data cleansing, supporting our Regulatory Affairs teams within the Operating Units and supporting our UDI Program team. This role primarily interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager and director.
We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.
Responsibilities may include the following and other duties may be assigned.
• Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs.
• Data entry activities
• Data mining and data cleansing activities
• Basic understanding of 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.
• Bachelor's degree
Nice to Have• Experience in medical device
• Experience with regulatory affairs or quality
• Experience with UDI
• Intermediate knowledge of word processing, 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. Tactful, exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral), team player, basic business acumen.
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)
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 here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
