Associate Regulatory Affairs Specialist - Onsite

About this role

We anticipate the application window for this opening will close on - 22 Aug 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life                     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.  Check us out on LinkedIn: Medtronic CST

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.

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

Required Knowledge and Experience:  • Requires a Baccalaureate degree

Nice-to-Have • 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

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.

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 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.

U.S. Work Authorization & Sponsorship At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. 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. ‌ Recruitment Fraud Alert We are aware of phishing scams targeting job seekers. Please keep the following in mind: 

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses. 

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate. 

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. 

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at AskHR@medtronic.com .  ‌ Benefits & Compensation   Medtronic offers a competitive Salary and flexible Benefits Package 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 sta

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