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Senior Regulatory Operations Specialist

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Regulatory Affairs
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20000GKE Requisition #

SENIOR REGULATORY OPERATIONS SPECIALIST

 

Careers That Change Lives

 

The Senior Regulatory Operations Specialist will partner with BU and global regulatory team members to manage, support and improve regulatory information systems and processes owned and driven by the Global RA Function (Corporate) in the areas of Submission Services and Regulatory Release. Responsibilities include BU support with Submissions and Global Trade Services (GTS)/SAP and Unique Device Identifier (UDI) product releases, driving process improvements to current activities and participate in future state development, participation in Corporate led regulatory projects, managing smaller projects, developing work instructions and training materials, influencing others to ensure alignment with Regulatory Information Management (RIM) requirements, and leading efforts to address other issues that are raised by business or regional groups to meet regulatory and/or business requirements.

           

A Day In The Life

As Snr Regulatory Operations Specialist, the primary role is to support business processes for a single specialized area or system: Publishing,  Product change control, (GTS)/SAP and UDI Coordination, and backup support for at least one of the other areas. Understand and follow all applicable areas quality policy/system procedures to ensure quality system compliance and high quality work.  Ability to manage multiple priorities and work with cross-functional teams at achieving tight deadlines will be required.

 

Submission Publishing Activities:

Responsible for assembly, publishing (paper and electronic) and filing of submissions.

This includes but is not limited:

·       Review and process incoming paper and electronic documents.

·       Support the creation of submission events in RAD and the association of products to the events.

·       Plan and oversee the assembly, printing, copying, distributing, shipping, and file management of regulatory submissions.

·       Assist with electronic publishing and archiving of regulatory submissions.

·       Complete regulatory agency forms and coordinate dispatch of submissions to the regulatory agency.

·       Work with the team of publishers on process improvement and documentation.

 

GTS coordination:

·       Creation of GTS licenses authorizing shipment of products

·       Run blocked order reports and cover GTS during expected work hours, with on-call support after hours on some days and holidays

·       Clearing of blocked orders in GTS system in a timely manner to minimize impact on customers (typically on the same day)

 

UDI coordination:

·       Collects, verifies and approves UDI Regulatory type data

·       Submits UDI to FDA and coordinates resolution of errors in a timely manner

·       Coordinates all Regulatory activities related to UDI Submission per applicable Work Instructions

 

 

Product Change Notification (PCN) Coordination (PCNC):

·       Coordinate the creation, monitoring, approval, and final filing of all change control documentation in the Regulatory Affairs Documentum (RAD) system.

·       Coordinate the communication of PCNs to all Neuromodulation Regulatory Affairs contacts inside and outside of the United States.

·       File all correspondence and final change control decisions.

·       Work with RAS staff from other Medtronic business units to identify best practices of managing PCN communication and assist in implementing new, more automated system.

 

In addition, this role may be required to:

  • Lead or participate in process improvement projects, approved changes or other change initiatives determined by leadership
  • Represent corporate regulatory on larger IT projects that require cross-BU, cross-regional, and/or cross-functional teams
  • Work with management/the team to develop overall training approach, including delivery methods, for regulatory system and/or process changes
  • Other project support for Regulatory Affairs/Operations team as requested, such as leading regulatory systems projects, troubleshooting, and system testing.
  • Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, and providing input to systems designs.
  • Due to the global nature of the role and the responsibilities, this role requires flexibility in order to support meetings and training sessions required for the various global time zones.

Must Have; Minimum Requirements

  • Bachelor’s degree and a minimum of 4 years of regulatory systems or quality systems experience 
  • Or advanced degree with a minimum of 2 years regulatory systems or quality systems experience. 

Nice To Have

  • Experience with Documentum or other document management systems used in the medical device/pharmaceutical industry.
  • Prior experience with electronic regulatory submissions and publishing software.
  • Working knowledge of submissions structures and the medical device development process related document requirements.
  • SAP experience
  • Microsoft applications, which includes working with templates, editing and formatting complex documents.
  • Advanced use of Adobe Acrobat and other Adobe plug-in publishing tools
  • Advanced knowledge level of Microsoft applications, which includes creating templates, editing and formatting complex documents in Word, PowerPoint, Visio and Excel.
  • Regulatory coursework
  • Experience working with cross-functional teams
  • Flexible with priorities and responsibilities
  • Effective organizational skills
  • Demonstrated oral and written communications skills
  • Experience in a professional regulatory or communications environment
  • Experience working med tech/healthcare industry/regulated environment preferred
  • High attention to detail, highly skilled in task management, task oriented
  • Direct regulatory affairs experience in the medical device or pharmaceutical industry
  • Ability to work independently with limited supervision; ability to appropriately escalate concerns and issues to leadership
  • Ability to work individually and in a team environment; may delegate or provide work direction to lower level specialists
  • Experience with creating and/or delivering training materials 
  • Flexibility Due to the global nature of the role and the responsibilities, this role requires flexibility in order to support meetings and training sessions required for the various global time zones

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.
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