Regulatory Operations Specialist
Medtronic Inc.
 Irvine, CA

Regulatory Affairs Operations Specialist - RTG Neurovascular

The Regulatory Affairs Operations Specialist will support the RA Ops team in the organization, analysis, reporting, implementation and maintenance of RA data, systems, processes and training. This position will provide support to the RA Groups in Business Unit-wide projects where RA information is required to scope, plan, and assess impacts on product registrations. In addition, this position will work closely with RA Management to establish processes within the Business Unit to support regulatory distribution control processes, RA data adequacy, FDA Establishment & Registration, CFG/FSC, RA reporting, and other RA system usage and implementations, 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.

Responsibilities:

  • Responsible to support Regulatory Affairs Management in the development, implementation, and maintenance of R.A. systems and processes.
  • Lead the implementation of system associated to SAP Global Trade Services (GTS);
  • Provide technical support on QARA systems and processes;
  • Participate in continuous improvement projects to improve processes and systems.
  • Support the SAP Global Trades Service (GTS) module for the Business Unit;
  • Develop and deploy new processes, templates and training within RA;
  • Recommend enhancements and make adjustments to systems and processes to solve problems and improve effectiveness and efficiency.
  • Support of Business Unit in issue resolution that arise from data and process inconsistencies;
  • Maintain current regulatory databases and systems and produce various reports and pull records and metrics as needed;
  • Maintain and provide regulatory information in support of initiatives for general scoping and planning for the BU RA teams;
  • Monitor and support consistent execution of training process and training programs.
  • Communicates regularly with peers and cross-functional partners to inform, gather input, and seek support for decision-making.
  • Provide training process expertise and records/reports from the LMS in support of quality system processes (i.e. internal and third-party audits, CAPAs) as requested.

The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

Medtronic Neurovascular is focused on creating life-saving devices to treat stroke. As part of the Brain Therapies Organization, we are revolutionizing how acute ischemic and hemorrhagic stroke is treated all over the world. We are focused on meeting our goal of no patient lost, no patient delayed, best patient outcome

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.

Must Have: Minimum Requirements (Must be evident on the resume)

  • Bachelor's Degree
  • 2+ years of experience in regulatory affairs, either in a regulatory products specialist role or regulatory operations role

Preferred Qualifications:

  • Experience Records and data management
  • Experience with Agile PLM
  • Strong ability with MS Excel
  • High attention to detail
  • Highly skilled in task management
  • Competent with MS Office (Word, Excel, PowerPoint, Visio, SharePoint, Access)
  • Working knowledge of SAP, Agile, or related system
  • Strong written/oral communication skills
  • Strong organizational skills and time management skills
  • Highly self-motivated
  • Experience in the medical device industry in Quality or Regulatory
  • Team player who seeks to help and learn from colleagues seeing the department success as their own
  • A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
  • Ability to manage small scale projects to completion within and outside
  • Previous experience supporting manufacturing and design changes a plus
  • Experience with Class III devices are a plus

Physical Requirements:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Position 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. 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). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • The employee is required to be independently mobile
  • The employee must be able to travel independently to various Medtronic buildings/sites.
  • The employee is required to interact with a computer, and communicate with co-workers
  • The employee is required to travel by car and by airplane (