Associate Regulatory Affairs Specialist - Onsite

Medtronic•Fort Worth, TX

6d•$60,800 - $91,200•Onsite

About The Position

As one of three comprehensive portfolios at Medtronic, Neuroscience is dedicated to improving the lives of people living with neurological disorders, spine conditions, and chronic pain. Guided by our Mission—to alleviate pain, restore health, and extend life—we develop technologies and therapies that help people regain function, reduce pain, and return to the activities that matter most. Our Cranial & Spinal Technologies (CST) operating unit advances surgical care for spine and cranial conditions through an integrated ecosystem of implants, navigation, robotics, imaging, and planning tools. Platforms like AiBLE enhance precision, efficiency, and outcomes for complex procedures worldwide. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. The Associate Regulatory Affairs Specialist will support regulatory activities related to the medical device Total Product Lifecycle, including product maintenance and global submissions.

Requirements

Requires a Baccalaureate degree
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
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.
Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

Open to feedback and continuous improvement
Experience/knowledge of MS Office Suite
Strong critical thinking and cross-functional collaboration skills
Ability to synthesize regulatory information for clear stakeholder communication
Self-starter with strong accountability and independent work style
Strong organizational skills with the ability to manage shifting priorities while maintaining quality and accuracy

Responsibilities

Supports cross-functional teams with changes as part of the Total Product Lifecycle (TPLC) with support from more senior team members
Supports changes to labeling, manufacturing, marketing, and clinical documentation to ensure regulatory compliance.
Compiles materials required for submissions, license renewals, and annual registrations.
Supports the preparation of document packages for regulatory submissions, internal audits, and inspections across all areas of the company.
Keeps abreast of regulatory procedures and changes.
May participate in interactions with regulatory agencies on defined matters.
Monitors and improves tracking/control systems.