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Associate Regulatory Affairs Specialist at Medtronic

Posted in General Business 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: Santa Ana, California

Job Description:


Careers that Change Lives
Together, we can change healthcare worldwide. At Medtronic, We push the limits of what technology 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.

The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one 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.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.


  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have: Minimum Requirements

0+ years w/ Bachelor's degree or 0+ years w/Master's degree experience in Regulatory Affairs, Engineering, Quality or Clinical

Nice to Have

  • Working knowledge of global medical device regulations, including submissions.

  • Demonstrated writing/technical writing skills.

  • Demonstrated Microsoft Word, Excel and Adobe software skills.

  • Experience in or exposure to combination devices.

  • Experience in or exposure to pharmaceutical regulations.

  • Experience working with cross-functional teams.

  • Experience working with technical documentation.

  • Effective verbal and written communication skills.

  • Effective organizational skills.

  • Experience with solving problems and concerns.

  • Attention to detail.

  • Effective negotiating skills.

  • Experience with project management and adherence to time schedules.

  • Quality or Regulatory compliance experience or background.

  • Self-motived

  • Work well under pressure in a dynamic environment.

  • Ability to audit own work to ensure compliance.

    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 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 Day in the Life 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.