We are currently seeking a **Staff Regulatory Affairs Specialist** to join our Mako and Enabling Technology business within the Joint Replacement Division to be based hybrid in Mahwah, NJ or Weston, FL. **What you will do** As the **Staff Regulatory Affairs Specialist** , you will work with minimal supervision to 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 mentor junior colleagues in the development of their regulatory skills. 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. You will assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies. + Provide regulatory guidance throughout all phases of new product development to ensure compliance with US, EU, and international requirements. + Develop and execute global regulatory strategies, including product classification, jurisdiction assessment, and risk mitigation planning. + Prepare and submit regulatory documentation (e.g., FDA submissions, EU design dossiers) to support product approvals and market access. + Collaborate with global affiliates to support international submissions and manage regulatory impact of product changes. + Review and approve labeling, marketing materials, and product claims to ensure regulatory compliance. + Interpret and apply regulatory requirements to clinical, nonclinical, and quality data for submission readiness. + Lead or contribute to regulatory interactions with authorities, including meetings, communications, and submission reviews. + Drive continuous improvement by updating SOPs, identifying process enhancements, and ensuring alignment with evolving regulations. **Required** + Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required. + 4+ years of experience in an FDA regulated industry required; preferably with medical devices. + 3+ years of Medical Device Regulatory Affairs experience + Experience drafting regulatory submissions for product approval + Thorough understanding of FDA, Europe and international medical device regulations **Preferred** + RAC certification or Advanced Degree (Masters in Regulatory Affairs) + General understanding of product development process and design control + General understanding of regulations applicable to the conduct of clinical trials + Previous experience with Class II/III medical devices + Previous experience drafting 510(k)s + Experience interacting with regulatory agencies $87,600 - $172,300 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors. Health benefits include: 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 include: 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. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. 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. Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.