Regulatory Affairs Specialist

A Day in the Life

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.

In this role, you will:

• 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.

To be considered for this role, you must have:

• Bachelor’s degree required
• Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.

Preferred qualifications include:

• 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