Summary

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.

Job description

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

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 escalate issues as needed to support resolution.
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 2 years 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.

Requirements

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

Benefits

Health, Dental & Vision Insurance
Health Savings Account
Healthcare Flexible Spending Account
Life Insurance
Long-term Disability Leave
Dependent Daycare Spending Account
Tuition Assistance
Incentive Plans
401(k) Matching
Short-term Disability
Paid Time Off
Paid Holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement
Capital Accumulation Plan

Company overview

Medtronic is a global healthcare technology leader and one of the world's largest medical device companies, founded in 1949 in Minneapolis, Minnesota. The company operates in over 150 countries and employs more than 90,000 people worldwide. Medtronic's mission is to alleviate pain, restore health, and extend life through innovative medical technologies. The company develops and manufactures devices and therapies to treat more than 70 health conditions, including cardiac devices, cranial and spine robotics, insulin pumps, surgical tools, patient monitoring systems, and more. With a rich history that began with the invention of the battery-powered pacemaker, Medtronic has grown into a diversified healthcare technology company with four main business units: Minimally Invasive Therapies Group, Diabetes Group, Restorative Therapies Group, and Cardiac and Vascular Group. The company's therapies help approximately 72 million people annually and represent a significant force in advancing medical technology to address some of humanity's most challenging health problems.