Principal Regulatory Affairs Specialist

  • MedTronic
  • Northridge, Los Angeles, CA, USA
  • Sep 22, 2020
Full time Admin-Clerical Business Development Design General Business Health Care Manufacturing Professional Services

Job Description

The Principal Regulatory Affairs Specialist, International is responsible for supporting and developing regulatory strategy, preparing global submissions and obtaining approval to introduce Medtronic Diabetes products and therapies to markets worldwide.This role focuses on regulatory support for the international markets outside of the US and EU. In this role, you will have RA responsibility for handling multiple Class I, Class II and Class III products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence.

A Day In The Life

  • Handle preparation and processing of documentation required for product registration of Medtronic Diabetes products in applicable international markets outside of the US and EU

  • Prepare international submissions for new product introductions, license renewals and product changes in assigned geographies

  • Manage and monitor progress of global submission activities for a variety of products and projects

  • Interact with local regulatory affairs team in country

  • Work with local regulatory staff and technical experts to resolve potential regulatory issues and questions from regulatory agencies

  • Support product shipment release

  • Review product/manufacturing changes and assess regulatory impact of product changes on international regulatory licenses and submissions

  • Maintain proficiency in worldwide regulatory requirements; monitor changes to regulatory requirements and communicate this information to departments that may be affected by these changes

  • Follow all work/quality procedures to ensure quality system compliance and high-quality work

  • Develop and maintain regulatory affairs department procedures

  • Perform other duties as assigned

Must Have: Minimum Requirements

  • Bachelors degree required

  • Minimum of 7 years of medical device regulatory experience, or advanced degree with a minimum of 5 years medical device regulatory experience

Nice to Have

  • Knowledge of US and international regulatory requirements including design control, medical device submissions requirements, labeling and promotion regulations, quality control, auditing principles, and adverse event reporting

  • Master’s Degree in Regulatory Science

  • Effective interpersonal/communication skills; demonstrated writing/technical writing skills

  • Strong analytical and critical thinking skills

  • Ability to effectively manage multiple projects and priorities

  • Organized, efficient, process-oriented; high attention to detail

  • Ability to learn and navigate software tools

  • Self-motivated and proactive team member

  • Ability to effectively manage multiple projects and priorities

  • Demonstrated Microsoft Word, Excel, Office, PowerPoint, and Adobe software skills 

Requisition Number: 20000EM8 

Zach Fuhr