Staff Regulatory Affairs Specialist (Remote)

About the role

This remote position supports Stryker’s Neurovascular division, focusing on bringing new medical devices to 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.

Responsibilities

• 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.

Requirements

• 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 Qualifications

• 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

Pay

• 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.

Benefits

• Health benefits: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.