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Regulatory Affairs Specialist International

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Regulatory Affairs
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19000EY3 Requisition #
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Regulatory Affairs Specialist (RAS) - International 

 

 

The International Regulatory Affairs Specialist is responsible for supporting and developing regulatory strategy, preparing global submissions and obtaining approval to introduce Medtronic Diabetes products and therapies to markets worldwide. This role focuses on regulatory support for the international markets outside of the US and EU. In this role, you will have RA responsibility for handling multiple Class I, Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

 

Position Responsibilities

 

• Handle the preparation and processing of documentation required for product registration of Medtronic Diabetes products in applicable international markets outside of the US and EU
• Prepare international submissions for new product introductions, license renewals and product changes in assigned geographies
• Interact with the regulatory affairs team in country
• Work with international regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies
• Support product shipment release
• Review Change Orders and assess regulatory impact of product changes on international regulatory licenses and submissions
• Maintain proficiency in worldwide regulatory requirements; monitor changes to regulatory requirements and communicate this information to departments that may be affected by these changes
• Follow all work/quality procedures to ensure quality system compliance and high-quality work
• Develop and maintain regulatory affairs department procedures
• Perform other duties as assigned


 

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.


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
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
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 (Engineering, science, or healthcare field preferred)
• 2+ years of regulatory experience in the medical device, biotech, or pharmaceutical industry with Bachelor’s degree.
• 2+months of regulatory experience in the medical device, biotech, or pharmaceutical industry with Master’s degree.

Desired/Preferred Qualifications:
 
• Knowledge of US and international regulatory requirements including design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reporting
• Effective interpersonal/communication skills; demonstrated writing/technical writing skills
• Strong analytical and critical thinking skills
• Ability to effectively manage multiple projects and priorities
• Organized, efficient, process-oriented; high attention to detail
• Ability to learn and navigate software tools
• Self-motivated and proactive team member
• Master’s Degree in Regulatory Science
• Ability to effectively manage multiple projects and priorities
• Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills

 
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.
• 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.
• 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 Overview
 
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.
 
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.
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
 
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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