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Sr Regulatory Operations Specialist

📁
Regulatory Affairs
📅
19000II3 Requisition #

Senior Regulatory Operations Specialist - Medtronic Diabetes Group 

 

The Senior Regulatory Operations Specialist will help lead process improvement efforts across the Regulatory Affairs Department, supporting submissions, developing, implementing and maintaining systems to capture key performance metrics, as well as streamlining product release activities for both US and International markets.

The successful candidate will help lead regulatory operations activities related to UDI submissions, GTS licensing, product release, and transition to EU MDR, as well as coach and review the work of lower level specialists and provide support for internal and external inspections.  The individual will manage multiple projects, requiring delegation of work and review of others' work product.


 

A Day in the Life  / Responsibilities:

 
• Run blocked order reports, coordinate block order resolution with Regulatory Affairs Specialists, solves routine issues with system and processes and manages resolution of blocked orders within tight timelines.
• Provide support for Global Trade Services (GTS) licensing, UDI submission for US and international markets
• Help lead efforts to streamline processes related to the EU MDR transition
• Create, develop and implement Regulatory Affairs product release process improvement activities
• Maintain and update assigned standard operating procedures, policies, work instructions, and user guides, as needed.
• Implement operational strategy, in cooperation with management, to archive correspondence, submissions, approvals, and other department regulatory documents, ensuring standardization, compliance, and integrity of archived documents and records.
• Serve as first-line user contact for training on Regulatory Affairs systems and procedures, troubleshooting and routine problem resolution related to system/business process integration.
• Understand regulatory guidelines on electronic submissions, general regulatory requirements, and internal procedures including business process/system integration.
• Initiate special projects with minimal direction from manager including collecting and analyzing data, and presenting results
• Develop key partnerships across functional groups and business units to ensure best practices.
• Participate in decision-making process for IT system enhancements and new support software implementation within regulatory affairs

 

Medtronic Diabetes Group

 

The Medtronic Diabetes Group offers an integrated system combining our MiniMed Insulin Pump Therapy with our Continuous Glucose Monitoring systems.  We are working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers. 
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe


 

Visit www.medtronicdiabetes.com  to see an overview of the products in our Diabetes product portfolio.


 

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.

 

Come for a job.  Stay for a career.

 

 
MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):
 
• Bachelor's degree
• 4+ years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Bachelor’s degree.
• 2+ years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Master’s degree.
 
 
DESIRED/PREFERRED QUALIFICATIONS:
 
• Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry
• Knowledge of GTS licensing, UDI coordination and EU MDR.
• Experience with Internet/Intranet technology and interactive software applications such as SharePoint and InfoPath.
• Advanced level knowledge and use of Microsoft Office Suite applications, Outlook, Word, Excel and Adobe Acrobat.
• Experience working with technical documentation and design dossiers.
• Ability to quickly learn new computer technology software packages with minimal training
• Analytical and problem-solving skills associated with software and complex documents, including the ability to detect, troubleshoot and rectify routine issues with systems.
• Expertise on general records management and archiving strategies
• Effective project management skills; ability to efficiently manage multiple projects and priorities
• Excellent written and verbal communication skills
• Strong customer service skills to interact with individuals at various levels of the organization and external contacts when necessary.
• Strong organizational and project management skills.  This includes meticulous attention to detail and the ability to complete multiple simultaneous assignments within a given period of time and with minimal supervision
• Ability to work with established procedures and to establish processes and procedures as needed, including the ability to understand policies and procedures necessary when working in a regulated environment.
• Motivated self-starter with the ability to perform independently or in teams in a fast-paced environment in response to business-critical assignments.

 
PHYSICAL 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.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<10%)
 
 
MEDTRONIC DIABETES GROUP
 
The Medtronic Diabetes Group offers an integrated system combining our MiniMed Insulin Pump Therapy with our Continuous Glucose Monitoring systems.  We are working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care, and improving outcomes; so people with diabetes can enjoy greater freedom and better health. Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers. 
This is a cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe
Visit www.medtronicdiabetes.com  to see an overview of the products in our Diabetes product portfolio.
 
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
 
 
ABOUT MEDTRONIC:
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

EEO STATEMENT:
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.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
 
 
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