Regulatory Affairs Specialist, Mako and Enabling Technologies; Remote

Staff Regulatory Affairs Specialist, Mako and Enabling Technologies (Remote)

Join Stryker’s Ortho Tech Business and support a portfolio that spans robotics, navigation, imaging, software, and capital equipment technologies. In this role, you will provide regulatory leadership throughout the product lifecycle, partnering with cross-functional teams to support global product development, regulatory submissions, market access, and ongoing regulatory compliance across U.S. and international markets.

This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone

• Develop and execute global regulatory strategies for new products, product changes, and lifecycle management activities.
• Participate in product development teams to ensure U.S., European, and international regulatory requirements are incorporated throughout all development phases.
• Evaluate product classifications, regulatory pathways, and jurisdictional requirements for medical devices and related technologies.
• Author and submit regulatory filings, including FDA submissions, international registrations, and supporting documentation required for product approvals.
• Review quality, preclinical, and clinical documentation to ensure submission readiness and regulatory compliance.
• Partner with global regulatory affiliates to support registrations, market expansions, and post-market regulatory activities.
• Lead interactions with regulatory authorities and notified bodies, including preparation of responses, submissions, and agency communications.
• Review product labeling, marketing materials, and product claims for compliance with applicable regulatory requirements and mentor junior regulatory team members on regulatory processes and best practices.

• Bachelor’s degree in Engineering, Sciences, Regulatory Affairs, or a related field.
• Minimum 4 years of experience in an FDA-regulated industry.
• Minimum 3 years of Regulatory Affairs experience.
• Experience preparing regulatory submissions for product approvals.

• Regulatory Affairs Certification (RAC) and/or Master’s degree in Regulatory Affairs or a related field.
• Experience supporting Class II and/or Class III medical devices.
• Experience authoring FDA 510(k) submissions.
• Experience interacting directly with regulatory agencies and notified bodies.

• 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

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