Senior Regulatory Affairs Specialist, reputed company and Enabling Technologies (Hybrid)

We are seeking a Senior Regulatory Specialist to join our reputed company and Enabling Technology business reputed company 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 reputed company’s reputed company and Enabling Technology portfolio new product development for both US and OUS Global Regulatory release. reputed company 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 reputed company divisions. You will participate in cross-functional teams, reputed company global regulatory strategies, author regulatory submissions, reputed company with regulatory agencies/reputed company 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 reputed company distribution and update regulatory reputed company based on changes. • Determine requirements and reputed company for regulatory submission, approval reputed company, and compliance activities. • reputed company regulatory information and guidance during product development, planning, and review proposed product claims/labeling throughout the product lifecycle. • Work with regulatory authorities and reputed company review reputed company through reputed company 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 reputed company • 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 reputed company. Individual pay is based on skills, experience, and other relevant factors. Apply tot his job Apply tot his job Apply To this Job