Regulatory Affairs Specialist

Medtronic•Mounds View, MN

1d•$74,400 - $111,600•Onsite

About The Position

Medtronic’s Access and Instruments Operating Unit develops technologies that support surgical access and enable precise, efficient procedures across a range of care settings. The portfolio includes products and solutions designed to help clinicians access the surgical site, perform procedures with greater control, and support workflow in the operating room. As part of Medtronic’s broader mission, this team is focused on advancing innovative tools that help improve procedural outcomes and support high-quality patient care. As a Regulatory Affairs Specialist in the Access and Instruments Operating Unit, you will play an important role in supporting innovative medical technologies throughout the product lifecycle. You will partner with cross-functional teams to prepare regulatory documentation, assess the impact of product changes, maintain regulatory systems, and help ensure compliance with global requirements. This role is ideal for someone who thrives in a collaborative environment, enjoys navigating complex regulatory requirements, and is energized by the opportunity to support technologies that improve patient care.

Requirements

Bachelor’s degree required
Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
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.
Candidates below the Principal level require unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Nice To Haves

Experience with U.S. FDA and international regulatory requirements for medical devices
Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
Experience supporting regulatory submissions, audits, or inspections
Strong written and verbal communication skills
Strong organizational skills with the ability to manage multiple priorities
Experience collaborating in a cross-functional, fast-paced environment
Familiarity with medical device product development or lifecycle management
RAC certification or progress toward certification
Experience working with Notified Bodies or global regulatory agencies

Responsibilities

Partner with multidisciplinary teams to communicate regulatory requirements and support regulatory strategy.
Provide regulatory input to product development, lifecycle planning, and change control activities.
Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes.
Prepare, review, and coordinate documentation for regulatory submissions, renewals, registrations, and related filings.
Support audits, inspections, and regulatory authority interactions as needed.
Participate in risk management activities and help ensure regulatory considerations are addressed appropriately.
Monitor and support tracking systems used to manage regulatory deliverables and documentation.
Stay current on applicable regulations, standards, and guidance documents relevant to assigned products and markets.
Collaborate with internal stakeholders to help resolve issues, manage priorities, and keep regulatory activities on track.
Contribute to process improvements and help strengthen regulatory practices across the organization.