Regulatory Operations Specialist
MedtronicAbout the role
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the Life
Sitting in the Diabetes Regulatory Operations Team, the Regulatory Operations Specialist will be a key member managing regulatory data attributes, distribution control mechanisms, and preparation and publishing of submissions.This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The successful candidate will:
- Have a background working within a Quality System
- Work cross-functionally and in a matrixed environment
- Manage multiple projects, prioritizing work based on criticality
- Have experience with FURLs and UDI data
- Have experience with and participate in continuous improvement activities
- Have experience with Regulatory Information Management (RIM) System
A Day in the Life
- Develop key partnerships with stakeholders across functional groups, and regions to align on harmonized processes
- Manage publishing activities for multiple projects
- Manage UDI Database including uploading of data to relevant regulatory bodies
- Manage FURLs Database including uploading of data
- Support Product Blocks and Product Release Activities
Must Have: Minimum Requirements
- Minimum 2 years of experience with a Bachelor’s Degree
- Or, advanced degree
Nice to Have:
- Strong project management skills.
- Proven ability to work globally.
- Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
- Excellent written and oral communication skills.
- Ability to think strategically and execute methodically.
- Ability to quickly learn new computer technology software packages with minimal training
- Ability to work effectively within a matrix environment
- Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
- Ability to influence cross-functional teams without formal authority.
- Strong attention to detail and an ability to deal with ambiguity
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
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.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
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.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations
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