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Regulatory Operations Specialist

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Regulatory Affairs
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19000EM3 Requisition #
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REGULATORY AFFAIRS OPERATIONS SPECIALIST

 

The Minimally Invasive Therapies Group (MITG) aspires to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive solutions. We help patients get better faster with fewer complications across all care settings. Our innovative therapies — developed in partnership with healthcare professionals — treat nearly 70 major patient conditions. They're used across the care continuum — from diagnosis to recovery — in a variety of specialties and procedures, and include:

  • Surgical technologies and instruments used in open surgery and minimally invasive surgery (MIS)
  • Devices that monitor patients during and after surgery
  • Technologies that allow doctors to monitor patients remotely
  • Equipment that supports and monitors patients’ breathing

Together, our solutions enable less invasive, more successful patient care — with earlier diagnosis, better treatment, and faster, complication-free recovery.

 

Careers That Change Live

 

The Regulatory Affairs Operations Specialist supports the MITG RA Ops team in the organization, analysis, reporting, implementation and maintenance of MITG RA data, systems, and processes.  This position will provide support to the MITG RA Groups during integration efforts and in MITG wide project where RA information is required to scope, plan, and assess impacts on product registrations.  Additionally, this position will work closely with RA Ops Manager to establish processes within MITG to support global change notification, RA data adequacy, certificate of analysis, FDA Establishment & Registration, RA reporting, and RA system usage, including training. This position will also focus on continuous improvement of RA processes, systems and documents across Medtronic to drive standardization and automation. The improvements require the position to create alignment, more consistent practices, and build partnerships across regulatory and other functions as needed.

 

A Day In The Life

  • Responsible to support QARA Ops Management in the development, implementation, and maintenance of QARA systems and processes. This includes but is not limited to:
  • Lead the implementation of system associated to Product Data Management for global registration management (InSight/RAD), product change notification (PCN) and Certificate of Analysis (CoA);
  • Provide technical support on QARA systems and processes;
  • Support the MITG global RA assessment of product change notification (PCN) using the Agile system;
  • Support the MITG US/EU registration data entry in InSight;
  • Support the FDA Establishment & registration process at MITG;
  • Develop and deploy new processes, templates and training within QARA;
  • Support MITG Business Unit in the organization and supply of RA data for GTS, Insight, PCN, and UDI (MDM) requirements;
  • Support of MITG Business Units in issue resolution that arise from data and process inconsistencies in RA Systems;
  • Maintain current regulatory databases and systems and produce various reports as needed;
  • Create and maintain up to date MITG QARA procedures;
  • Maintain and provide regulatory information in support of MITG wide initiatives for general scoping and planning for the BU RA teams;
  • Improve regulatory intelligence by attending regulatory seminars and meetings.

 


Must Have: Minimum Requirements
  • Bachelors degree required
  • Minimum 2 years of  regulatory affairs submittal or regulatory operations experience
  • OR Advanced degree with 0 years of experience
Nice To Have
  • Regulatory or quality experience in medical device industry.
  • General knowledge of industry practices, techniques and standards.
  • Experience in regulatory affairs, either in regulatory product specialist role or regulatory operations role. 
  • High attention to detail, highly skilled in task management, task oriented. 
  • Records and Data Management
  • Microsoft applications, which includes working with templates, and editing and formatting complex documents. 
  • Proficiency in Excel with ability to convert data for more effective analysis.
  • Working knowledge and/or experience working in InSight, Agile or other related system.
  • Excellent communication skills (written and verbal). 
  • Strong critical thinking and analytical skills.
  • Experience with Internet/Intranet technology, SharePoint, and other interactive software applications.
  • Agility to manage changing priorities, responsibilities, and timelines. 
  • Effective organizational skills and attention to detail.
  • Strong work ethic. 
  • Works well under pressure in a dynamic environment.
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)



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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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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