Regulatory Affairs Specialist, Medical Devices (Onsite)

Medtronic; Minneapolis (MN); Presencial; USD 90.000 - 120.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory affairs

FDA regulations

Regulatory submissions

Cross-functional collaboration

Educación

Bachelor's degree in a scientific discipline

Herramientas

Microsoft Office

Descripción del empleo

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.