Senior Regulatory Affairs Specialist
Medline Industries, LP
full-time
Posted on:
Location Type: Hybrid
Location: St. Paul • Illinois • Minnesota • United States
Visit company websiteExplore more
Salary
💰 $92,000 - $138,000 per year
Job Level
About the role
- Responsible for planning and executing critical and complex global regulatory projects
- Prepare comprehensive regulatory strategies for new devices and markets
- Communicate requirements of regulations to internal or external customers
- Review and provide directions to ensure supporting evidence meets regulatory requirements
- Lead internal groups and collaborate with external groups on regulatory filings
- Manage individual projects defining timelines and recommending actions
- Assist in the review and development of processes related to regulatory activities
Requirements
- B.A. or B.S. degree in life science field (biology, microbiology, chemistry, etc.), engineering, medical technology, regulatory science, or related
- At least 4 years of experience in regulatory affairs in the medical device industry
- Experience authoring and submitting regulatory submissions including 510(k)s and/or CE Technical Files
- Experience in preparing responses and communicating with regulatory agencies
- Understanding of the current Regulatory environment
- Applied knowledge of FDA regulations and guidelines
- Position requires up to 10% travel
Benefits
- Health insurance
- Life and disability insurance
- 401(k) contributions
- Paid time off
- Continuing education & training
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategiesregulatory submissions510(k)CE Technical FilesFDA regulationsregulatory requirementsproject managementprocess developmentregulatory filingsregulatory affairs
Soft Skills
communicationcollaborationleadershipplanningexecutiondirection providingcustomer interactiontimelines managementaction recommendationproblem-solving