Regulatory Affairs Specialist

Medtronic•Lafayette, CO

1d•Onsite

About The Position

The Regulatory Affairs Specialist supports international regulatory strategies and submission activities across global markets. The role assists with new product registrations, renewals, amendments, and country-specific regulatory requirements to help ensure compliance and maintain market access. The specialist works 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. The role supports global submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA, while tracking timelines, identifying submission risks, responding to health authority questions, and supporting regulated product lifecycle management. This is an on-site position based in North Haven, Connecticut; Lafayette, Colorado; Mansfield, Mississippi; or Mounds View, Minnesota. The position requires a bachelor’s degree and at least two years of relevant experience, or an advanced degree and at least zero years of relevant experience.

Requirements

Bachelor’s degree required.
At least two years of relevant experience, or an advanced degree with at least zero years of relevant experience.
Candidates for work in the United States below the Principal level must have unrestricted U.S. work authorization at the time of hire and for the duration of employment.
For baccalaureate degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

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 and 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

Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
Compile materials 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, accuracy, and consistency.
Manage multiple projects, tracking deadlines, action items, and submission status to support timely execution.
Identify regulatory risks, gaps, and delays early, and escalate issues as needed.
Communicate regulatory requirements clearly to internal and external stakeholders.
Stay current with regulatory procedures, guidelines, and changes in global requirements, and communicate relevant updates internally.
Apply sound judgment, collaborate with stakeholders, and assist team members as needed.
Identify opportunities to streamline submission processes, trackers, and cross-functional ways of working.