Regulatory Affairs Specialist

Medtronic plc; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Medtronic plc, a global leader in healthcare technology, seeks a Regulatory Affairs Specialist to support international regulatory strategies and submissions for medical devices. You will collaborate with Quality, Clinical, Manufacturing, and Marketing to ensure timely registrations and market access.

This on-site role may be based in North Haven, CT or Lafayette, CO, covering submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA.

Qualifications

• Bachelor's degree required.
• Minimum of 2 years of relevant regulatory experience.
• Experience with medical device regulatory submissions and audits preferred.

Responsibilities

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
• Compile materials required for global submissions, license renewals, amendments, and responses to health authority inquiries.
• Assess regulatory requirements and help recommend submission strategies based on business needs, risk, and timelines.
• Support critical, complex, and time-sensitive registrations while balancing compliance and operational priorities.
• Review regulatory, technical, quality, labeling, and product documentation for completeness and accuracy.
• Manage multiple projects with deadlines, action items, and submission status.
• Identify regulatory risks, gaps, and delays early and escalate as needed.
• Communicate regulatory requirements clearly to internal and external stakeholders.
• Stay current with evolving global regulatory requirements and updates.

Skills

Regulatory compliance

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree

Job description

We anticipate the application window for this opening will close on - 3 Nov 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.

A Day in the Life

The Regulatory Affairs Specialist supports international regulatory strategies and submission activities across global markets. This role is responsible for assisting with new product registrations, renewals, amendments, and other country-specific regulatory requirements to help ensure compliance and maintain market access.

The Regulatory Affairs Specialist works closely with regional regulatory colleagues and cross-functional teams, including Quality, Clinical, Manufacturing, and Marketing, to support submission readiness, coordinate documentation, and contribute to timely execution.

This is an on-site position and may be based in North Haven, CT; Lafayette, CO; Mansfield, MS; or Mounds View, MN. The role supports global submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA, while helping track timelines, identify submission risks, respond to health authority questions, and support the lifecycle management of regulated products

Responsibilities may include the following and other duties may be assigned.

• Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
• Compile materials required for global submissions, license renewals, amendments, and responses to health authority inquiries.
• Assess regulatory requirements and help recommend appropriate submission strategies based on business needs, risk, and timelines.
• Support critical, complex, and time-sensitive registrations while balancing compliance and operational priorities.
• Review regulatory, technical, quality, labeling, and product documentation for completeness, accuracy, and consistency.
• Manage multiple projects simultaneously while tracking deadlines, action items, and submission status to support timely execution.
• Identify regulatory risks, gaps, and delays early and escal…
• Communicate regulatory requirements clearly to internal and external stakeholders to support informed decision‑making.
• Stay current with regulatory procedures, guidelines, and changes in global requirements.
• Apply sound judgment to support regulatory activities, collaborate with stakeholders, and assist team members as needed.
• Maintain awareness of evolving global regulatory requirements and communicate relevant updates to internal teams.
• Support continuous improvement by identifying opportunities to streamline submission processes, trackers, and cross-functional ways of working.

Must Have: Minimum Requirements

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

Nice to Have

• 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.

Physical Job Requirements

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 successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, 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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtro