Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 17 Aug 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.

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.

• 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.

• Bachelor’s degree required

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

• 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

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 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…