Staff Regulatory Affairs Specialist (Remote)

We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States. As the Staff Regulatory Affairs Specialist, you will support maintaining medical devices on the market and ensure ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling, and evaluate proposed device changes in major markets including the US, EU, Canada, Australia, Brazil, Japan, and more. What you will do

• Develop and execute regulatory strategies for pre-market and post-market products to maintain market access across global regions.
• Evaluate regulatory requirements and identify submission pathways for product changes, ensuring alignment with applicable regulations.
• Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals and updates.
• Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
• Partner with cross-functional teams to support regulatory agency interactions, including responses, meetings, and documentation.
• Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
• Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
• Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.

What you need Required

• Bachelor’s Degree (B.S. or B.A.)
• Minimum 4 years of experience in an FDA-regulated industry
• Minimum 2 years of experience in regulatory affairs
• Demonstrated applied knowledge of FDA and international medical device regulations/standards (e.g. EU MDR)

Preferred

• Bachelor’s degree in engineering, science, or related field
• Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline
• Experience with Class II or Class III medical devices
• Experience authoring 510(k) submissions or equivalent regulatory filings
• Experience interacting with regulatory agencies or supporting regulatory meetings

Posted Date: 08/20/2026 This role will be posted for a minimum of 3 days. United States of America Pay Ranges:

• Puerto Rico: $77,700 - $129,500 USD Annual
• USN: $95,700 - $159,500 USD Annual
• US5: $100,500 - $167,500 USD Annual
• US10: $105,300 - $175,500 USD Annual
• US15: $110,100 - $183,400 USD Annual
• US20: $114,800 - $191,400 USD Annual
• US30: $124,400 - $207,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.