Senior Regulatory Affairs Specialist, Mako and Enabling Technologies (Hybrid)

We are seeking a Senior Regulatory Specialist to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid two to three days per week in Mahwah, NJ or Weston, FL. What you will do As the Senior Regulatory Affairs Specialist, you will support Stryker’s Mako and Enabling Technology portfolio new product development for both US and OUS Global Regulatory release. Mako and Enabling Technologies portfolio covers three technology pillars, robotics, navigation and imaging which includes capital equipment, navigation, robotics, software devices, and/or associated accessories and instruments and provides unique opportunities to collaborate across various Stryker divisions. You will participate in cross-functional teams, develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review labeling and marketing material, and evaluate proposed device changes. • Assess regulatory landscape to create the development of global regulatory strategies • Identify requirements and anticipate regulatory obstacles for market access distribution and update regulatory strategy based on changes. • Determine requirements and options for regulatory submission, approval pathways, and compliance activities. • Provide regulatory information and guidance during product development, planning, and review proposed product claims/labeling throughout the product lifecycle. • Work with regulatory authorities and track review progress through clear communication. • Identify the need for new regulatory procedures, SOPs, and helps train stakeholders to ensure organization-wide compliance. • Prepare and submit electronic submissions, ensuring consistency with regulatory requirements. What you need Required • Bachelors Degree in Engineering, Science, or related • 3+ years of experience in an FDA regulated industry • 2+ years of experience in medical device regulatory affairs • Thorough understanding of FDA, Europe, and international medical device regulations • Experience drafting regulatory submissions for product approval Preferred • RAC certification or Advanced Degree (Masters in Regulatory Affairs) • Previous experience with Class II/III medical devices • Previous experience drafting 510(k)s • Experience interacting with regulatory agencies $87,600.00 - $148,400.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors. Apply tot his job Apply tot his job