Regulatory Affair Specialist - Onsite

Medtronic•Minneapolis, MN

2d•$74,400 - $111,600•Onsite

About The Position

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.

Requirements

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.
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.
U.S. work authorization is required for this role, as sponsorship is only offered for Principal-level roles and above.

Nice To Haves

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.

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.