1+ months

Senior Regulatory Operations Specialist - Diabetes

Medtronic
Northridge, CA 91325
Senior Regulatory Operations Specialist - Diabetes

Location:

Northridge, California, United States

Requisition #:

20000A7J

Post Date:

Jun 24, 2020


**SENIOR REGULATORY OPERATIONS SPECIALIST - DIABETES**


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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


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.


**Careers That Change Lives**


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 Submission information and communication management, 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**


+ Manages and provides metrics for FDA and Notified Body communications in a centralized database.

+ Implements 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.

+ Solves routine issues with system and processes

+ Provides support for UDI submissions for US and international markets

+ Helps lead efforts to streamline processes related to the EU MDR transition

+ Creates, develops and implements Regulatory Affairs product release process improvement activities

+ Maintains and updates assigned standard operating procedures, policies, work instructions, and user guides, as needed.

+ Serves as first-line user contact for training on Regulatory Affairs systems and procedures, troubleshooting and routine problem resolution related to system/business process integration.

+ Understands regulatory guidelines on electronic submissions, general regulatory requirements, and internal procedures including business process/system integration.

+ Initiates special projects with minimal direction from manager including collecting and analyzing data, and presenting results

+ Develops key partnerships across functional groups and business units to ensure best practices.

+ Participates in decision-making process for IT system enhancements and new support software implementation within regulatory affairs


**Must Have; Minimum Requirements**


+ Bachelors Degree

+ Minimum 4 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with Bachelors degree.

+ Minimum 2 years of medical device experience with work experience in regulatory affairs/regulatory operations or quality with an advanced degree.


**Nice To Have**


+ Experience with Regulatory Affairs Domain (RAD) or similar document submission database in the medical device or pharmaceutical industry

+ Experience with Agile, Documentum or other document management systems used in the medical device or pharmaceutical industry

+ Knowledge of UDI within the US and internationally.

+ 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.

+ Ability to quickly learn new computer technology software packages with minimal training

+ 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

+ 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 efficiently manage multiple projects and priorities 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.


**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. Lets 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)
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.

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Posted: 2020-06-26 Expires: 2020-09-04

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Senior Regulatory Operations Specialist - Diabetes

Medtronic
Northridge, CA 91325

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