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Regulatory Affairs Operations Specialist - Diabetes

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Regulatory Affairs
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1900001U Requisition #
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REGULATORY AFFAIRS OPERATIONS SPECIALIST -DIABETES

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


Careers That Change Lives  

 

In this role,  you will provide support to Regulatory Operations and Regulatory Affairs Department, including oversight, manipulation and updating of data to Corporate and Diabetes SAP Modules and Regulatory Affairs Database (RAD), as well as assisting in the preparation, handling, and publishing of regulatory submissions (e.g. PMA, 510k). Additionally, this position assists with product release to market and ensuring all regulatory requirements for product release are met.

 

A Day in the Life

• Masters product line and identification information, and provides sustaining support around this, including updating and maintaining data tabulations.

• Ensures accuracy and comprehensiveness of product data for submission to Global Unique Device Identification Database (GUDID).  GUDID is a FDA database containing product specification and identification information under FDA’s Unique Device Identifier (UDI) rules.

• Ensures quality and timely preparation of GUDID submissions.

• Performs various administrative duties, including back-up assistance to Regulatory Affairs Database (RAD) publishing, data management and UDI Coordinator Roles.

• Liaison to our Document Control Department regarding the issuance and maturation of Global Trade Identification Number, a component of UDI (GTIN) numbers as part of meeting FDA’s UDI rules.

• Liaison to our Medical Device Reporting group, particularly as concerns, but not necessarily limited to, UDI-related changes.

• Reviews, updates and processes correspondences, documents and reports, e.g., in RAD

• Collaborates with cross-functional teams to develop and implement best practices that ensure the timely release of product and meet regulatory requirements and business needs.

• Develops, implements, and updates processes and procedures for meeting compliance in regards to product release and product reporting (e.g. UDI compliance).

• Effectively communicates information, status, and resource requirements with regulatory operations team and management.

• Other duties as assigned

• General utility role with Regulatory Affairs

• Ability to travel up to 10%

 


Must Have; Minimum Requirements:

Nice to Have:

  • Bachelor’s degree in Regulatory or related field
  • Experience in Regulatory, Operations and/or Quality
  • Project/program management experience
  • Knowledgeable of Medical Device Reporting (MDR) process and interested in becoming Regulatory Affairs Certified (RAC) to better assist department needs
  • Proficiency in an Enterprise Reporting System (ERP), such as SAP.
  • Knowledge of Diabetes products
  • General knowledge of medical terminology
  • Demonstrated proficiency using MS Office applications (i.e. Outlook, email, Excel, Word, and PowerPoint)
  • Knowledge of applicable US regulations, including 21 CFR Part 820 and 803 and HIPAA
  • Knowledge of international medical device regulations
  • Degree or course work in Regulatory Compliance and/or Quality Assurance a plus
  • Quality focused with strong organizational skills
  • Excellent reading comprehension in English
  • Must be detail-oriented, accurate and organized while handling multiple tasks
  • Excellent interpersonal and communication skills
  • Ability to work productively and positively with team members and cross-functionally in a large organization
  • Must be able to work flexible hours that may include working occasional weekends or evenings


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)

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