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 Stryker’s neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams, develop global regulatory strategies, author regulatory submissions, and interact with regulatory agencies/notified bodies in major markets including the US, EU, Canada, Japan, China, Australia, Brazil, and more.

What you will do

• Develop and execute regulatory strategies for pre-market products to achieve market access across global regions.
• Evaluate regulatory requirements and identify submission pathways for new products , ensuring alignment with applicable regulations.
• Author and submit regulatory documents, including FDA submissions and international dossiers, to support product approvals.
• 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.