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Regulatory Affairs
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21000JDI Requisition #

PRINCIPAL REGULATORY AFFAIRS SPECIALIST

Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident —we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

Careers That Change Lives

The Principal Regulatory Affairs Specialist will manage the interpretation and implementation of enterprise wide quality management system documents for new and changing regulations.  Sitting in the newly created Global Regulatory Shared Service team, the Principal Regulatory Affairs Specialist will be a key team member in enterprise programs, partnering with Regional stakeholders on new requirements, assessing the impact, obtaining stakeholder feedback, establishing consistent interpretation, and enable Operating Unit readiness and execution.

The successful candidate will:

  • Have a strong background with translating requirements into processes and procedures
  • Have experience supporting internal and external inspections
  • Have a process mindset to guide practical implementation of requirements
  • Work cross-functionally and in a matrixed environment
  • Manage multiple projects, requiring delegation of work and review of others' work product
  • Have experience with continuous improvement activities

A Day in the Life

  • Develops key partnerships with stakeholders across functional groups, operating units, and regions to align on harmonized interpretation.
  • Analyze current state of Quality Management System documents to ensure connectivity across processes.
  • Drive knowledge sharing across the enterprise in support of a consistent interpretation and alignment with enterprise policies and procedures.
  • Partner with Regulatory Operations to improve how systems support compliance.
  • Partner with Quality Management System resources to develop implementation strategy
  • Initiates special projects with minimal direction from manager including collecting and analyzing data, and presenting results
  • Manage project status reports for implementation efforts across various regulatory workstreams
  • Mentor and direct colleagues in achieving department objectives and in compliance with policies and procedures.

Must Have: Minimum Requirements

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

Nice To Have 

  • Strong project management skills.
  • Proven ability to work globally.
  • Experience with new and changing regulations (ex. European Union Medical Device Regulation)
  • Self-motivated, entrepreneurial, independent, driven individual to meet objectives.
  • Excellent written and oral communication skills.
  • Ability to think strategically and execute methodically.
  • Ability to work effectively within a matrix environment
  • Ability to multitask and prioritize while managing multiple projects and day to day responsibilities
  • Ability to influence cross-functional teams without formal authority.
  • Strong attention to detail and an ability to deal with ambiguity

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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Learn more about our benefits:  benefits.medtronic.com

This position is eligible for a short-term incentive plan.  Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6 here.

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