Regulatory Affair Specialist - Onsite

Medtronic; Minneapolis (MN); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Medtronic is seeking a Regulatory Affairs Specialist to support regulatory strategy, submissions, and compliance for global medical devices. You will partner with engineering, quality, clinical, and manufacturing teams to ensure registrations and maintain compliance across markets.

The role focuses on preparing submissions (510(k), PMA, EU MDR) and guiding product changes through regulatory processes while collaborating with international teams. Onsite in Minnesota with regular office presence.

Competenze

• Bachelor's degree in a scientific discipline required.
• Experience with FDA requirements and regulatory submissions highly preferred.
• Strong proficiency with MS Office tools and document drafting.

Mansioni

• Prepare and support regulatory submissions for the United States, EU, Canada and other global markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams to assess regulatory requirements for product changes and new product introductions.
• Develop regulatory documentation to support product registrations, renewals, annual reports, and change notifications.
• Review product labeling, technical documentation, and design changes for regulatory impact and compliance.
• Support interactions with regulatory authorities and respond to regulatory inquiries under the manager's guidance.
• Partner with global regulatory teams to obtain market approvals and maintain product registrations.
• Support regulatory compliance activities, including manufacturing site registrations, audits, vigilance reporting, and recall-related activities.
• Provide regulatory guidance to product development teams throughout the product lifecycle.

Conoscenze

Regulatory affairs

FDA regulations

Regulatory submissions

Cross-functional collaboration

Formazione

Bachelor's degree in a scientific discipline

Strumenti

Microsoft Office

Descrizione del lavoro

We anticipate the application window for this opening will close on - 24 Oct 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

Our Neuroscience portfolio includes the Neuromodulation and Pelvic Health Operating Units, which deliver implantable and minimally invasive therapies to address chronic pain, movement disorders, bladder and bowel control conditions, and other nervous system disorders. The Regulatory Affairs function partners with product development, quality, clinical, manufacturing, and global regulatory teams to support product registrations, regulatory compliance, and lifecycle management activities across global markets.

This position is based at Medtronic's Rice Creek East campus in Minnesota and follows an onsite work model with a minimum of four days per week in the office.

The Regulatory Affairs Specialist supports regulatory strategy, submissions, approvals, and compliance activities for medical devices marketed globally. This role partners with cross-functional teams and international regulatory stakeholders to facilitate product registrations, support product changes, and maintain compliance with applicable regulatory requirements.

Primary Responsibilities

• Prepare and support regulatory submissions for the United States, European Union, Canada, and other global markets.
• Collaborate with engineering, quality, clinical, and manufacturing teams to assess regulatory requirements for product changes and new product introductions.
• Develop regulatory documentation to support product registrations, renewals, annual reports, and change notifications.
• Review product labeling, technical documentation, and design changes for regulatory impact and compliance.
• Support interactions with regulatory authorities and respond to regulatory inquiries under the manager's guidance.
• Partner with global regulatory teams to obtain market approvals and maintain product registrations.
• Support regulatory compliance activities, including manufacturing site registrations, audits, vigilance reporting, and recall-related activities.
• Provide regulatory guidance to product development teams throughout the product lifecycle.

Required Qualifications

• Bachelor's degree in a scientific discipline and 2+ years of experience in regulatory affairs, quality, clinical, or medical device-related roles.
• Experience supporting medical devices regulated under FDA requirements, including Class II and/or Class III products.
• Experience preparing or supporting regulatory submissions, including 510(k), Premarket Approval (PMA), European Union Medical Device Regulation (EU MDR), or international regulatory filings.
• Knowledge of FDA regulations, EU MDR requirements, ISO 13485, and ISO 14971 standards.
• Proficiency with Microsoft Office applications.

Preferred Qualifications

• 2+ years of regulatory affairs experience within the medical device industry.
• Advanced degree in engineering, biological sciences, physical sciences, or health sciences.
• Experience supporting global product registrations and regulatory approvals across multiple regions.
• Experience working in regulated biotechnology or medical device manufacturing environments.
• Experience interacting with regulatory agencies and supporting agency responses.
• 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 environme