# Regulatory Affairs Specialist at Coloplast

Coloplast is hiring a Regulatory Affairs Specialist in Minneapolis, United States. It pays $110k-$150k a year and Level rates it Little AI ●○○○; you can [apply on Coloplast](https://jobsbylevel.com/go/8d0f2b23-5b51-4992-be5c-73b529bc7242?utm_medium=ai-agent).

AI Level 1, AI centrality 38 out of 100. Minneapolis, MN.

## Details

- Company: [Coloplast](https://jobsbylevel.com/companies/coloplast)
- AI level: AI Level 1 (score 38 out of 100)
- Location: Minneapolis, MN
- Salary: $110k-$150k
- Posted: November 3, 2026
- Apply: https://jobsbylevel.com/go/8d0f2b23-5b51-4992-be5c-73b529bc7242?utm_medium=ai-agent
- Free CV review for this job: https://jobsbylevel.com/cv-review?job=regulatory-affairs-specialist-at-coloplast-5469a9

## Description

div.content { background: #6c6f70 } div.joqReqDescription { background: #FFF repeat-y; !important; font family: arial; !important text-align: left; color: #000; width: 900px !important; margin: 0 auto !important; position: relative; -webkit-column-count: 1; -moz-column-count: 1; padding-top: 489px; padding-left: inherit; padding-bottom: 50px; } div.joqReqDescription strong{ font family: arial; font-size: 14px; color: #000; } div.joqReqDescription p{ font family: arial; padding-left:0px; width: 892px; } div.joqReqDescription div.image-box { width: 900px; text-align: center; display: block; top: 0px; left: 5px; position: absolute; height: 150px; } div.joqReqDescription div.header-box { background-color: #00b0ca; position: absolute; top: 389px; display: block; font-family: arial !important; font-size: 30px; color: rgb(255, 255, 255); font-weight: bold; width: 883px; left: 5px; height: 72px; padding-left: 17px; padding-top: 15px; } The Regulatory Affairs Specialist applies regulatory expertise and business knowledge to ensure medical devices are developed, registered, commercialized, and maintained in compliance with applicable regulatory requirements throughout the product lifecycle in the United States and Canada. Serves as a regulatory affairs representative for United States and Canadian medical device regulatory activities, collaborating with global regulatory, quality, clinical, product development, and commercial teams. Major Areas of Accountability Develop and execute regulatory strategies for new product introductions, product modifications, license maintenance activities, and market expansion initiatives in the United States and Canada. Prepare and submit FDA regulatory submissions including Traditional, Special, and Abbreviated 510(k) Notifications as applicable. Prepare, submit, and maintain Health Canada Medical Device License (MDL) applications, amendments, annual license renewals, and license maintenance activities. Conduct regulatory impact assessments and determine regulatory requirements associated with design, manufacturing, labeling, supplier, software, and process changes. Act as regulatory liaison for assigned geographies by ensuring that local regulatory requirements, pathways and registration needs are anchored in global regulatory strategies and executed at a local level, through transparent and clear communication and focus on collaborative work and solution. Review and approve product labeling, IFUs, packaging artwork, UDI content, and promotional materials to ensure compliance with FDA and Health Canada requirements. Assess transferability of global product claims per local requirements, and review advertising materials for regulatory compliance. Report information into applicable data management systems and maintain internal/external regulatory databases. Monitor and analyze emerging regulatory intelligence for the assigned geographies. Participate in development, maintenance and implementation of regulatory procedures, instructions and systems. Participate in preparation and execution of audits/inspections Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies. Other job duties as assigned Basic Qualifications Minimum Bachelor’s degree or equivalent relevant work experience. Minimum 2 years relevant work experience with direct exposure to regulatory affairs in the medical device industry, or other relevant regulated industry sectors. Cross-functional: business & value chain understanding, self-management, decision-making and critical thinking, collaboration & communication. Functional competencies: quality management system and processes, regulations, standards and sustainability, design control & validation. Ability to travel up to 10% for internal meetings, audits, inspections, and professional development

The description is cut here. Read the full offer: https://jobsbylevel.com/jobs/regulatory-affairs-specialist-at-coloplast-5469a9

Source: https://jobsbylevel.com/jobs/regulatory-affairs-specialist-at-coloplast-5469a9

## Cite this page

Level. https://jobsbylevel.com/jobs/regulatory-affairs-specialist-at-coloplast-5469a9.

Get job alerts: https://jobsbylevel.com/newsletter