Staff Regulatory Affairs Specialist in Mahwah

Work Flexibility: 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. Work Flexibility: This is a remote position, with a preference for candidates located in the U.S. Eastern Time Zone What You Will Do 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

Work Flexibility: Field-based Due to the nature of this role and travel requirements associated with this role, we will accept candidates from the 48 continental United States. Job Summary: As a National Leaves Clinical specialist, you will work directly with a JR/MPS team to support robotic and manual joint replacement procedures. You will be required to work within RepSuite for scan and schedule management in multiple territories across the country for employee leave of absence and when otherwise needed by the business. The NLCS will directly report to the Senior Manager, LEAP but indirectly work alongside local Mako Manager, JR Sales Manager, and GM. When not deployed the NLCS will assist and train with local JR team and execute all necessary clinical functions with that team. Field assignments can be a short as two week and as long as 3 months or more. Essential Duties & Responsibilities: Clinical Expertise in robotic applications Develop and maintain expert-level knowledge of Mako robotic systems, their functionalities, and clinical applications. Develop and maintain expert-level knowledge of manual joint replacement instrumentation and implants. Serve as a clinical resource to healthcare professionals, offering insights, training, and support. Deliver comprehensive customer experience tailored to surgeons, nurses, and other clinical staff during the deployment. Ensure that healthcare teams are proficient in MAKO technology, understand clinical benefits and have access to program resources. Be a point of contact for clinical inquiries, troubleshooting, and technical support related to Mako and manual instrumentation and implants. Relationship Building: Build and maintain strong relationships with healthcare providers and hospital staff, internal team members and potential new c