Senior Regulatory Affairs Specialist - Neurovascular at Medtronic in Irvine, California

Posted in General Business 7 days ago.

Type: Full-Time

Job Description:


The Neurovascular Operating Unit offers an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.

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 Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes.

A Day In The Life

  • Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
  • Assist in keeping company informed of regulatory requirements in the US and EU.
  • Participate on Product Development teams by providing regulatory strategy, timelines, and direction.
  • Prepare US and EU submissions. Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.
  • Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.
  • Review labeling, training, promotional and advertising material.
  • Support post market regulatory compliance activities for US/EU product approvals.
  • Develop and maintain regulatory affairs department procedures and process improvements
  • Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct
  • Assist in keeping company informed of regulatory requirements in the US and EU.

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

  • Bachelor's Degree
  • 4+ years of US/EU medical device regulatory submission experience with Bachelor's degree or 2+ years of US/EU medical device regulatory submission experience with Master's degree

Nice To Have

  • Knowledge of FDA and EU requirements
  • 510(k) or PMA submission experience
  • Strong communication skills
  • Strong technical writing skills
  • Regulatory Affairs Certification
  • Master's degree in Regulatory Affairs or Engineering
  • PMA experience
  • IDE experience

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)

Additional Information

  • Posting Date: Feb 19, 2021
  • Travel: No