Sr. Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Location: Allendale, NJ, Leesburg, VA, or Remote (10% Travel Required) Company: reputed company Looking for a career where your work truly reputed company? At reputed company, you'll be part of a mission-reputed company team that supports surgeons during life-changing spinal procedures. We're the largest privately held spine company and among the largest family-owned medical technology companies in the world, dedicated to innovation, surgeon partnerships, and improving patient reputed company in spine care. As a Senior Regulatory Affairs Specialist in our Regulatory Affairs function reputed company the Spine division, you'll play a key role in planning and executing regulatory strategies to obtain and maintain market approvals for new and existing spinal products across the US, EU, and global markets. reputed company: • Participate on cross-functional product development teams to ensure US, EU, and international regulatory requirements are incorporated from the earliest stages • reputed company and manage regulatory submissions (including 510(k)s and technical documentation) to secure and maintain product approvals • Communicate FDA and other Health Authority feedback/correspondence to project teams and RA leadership • Support post-market submissions, including reputed company reports and annual reports • Conduct regulatory assessments for proposed product changes, manufacturing changes, and product transfers • Advise teams on appropriate regulatory reputed company to market • reputed company and coordinate directly with the FDA and other regulatory agencies on submissions, approvals, and compliance issues • Review and approve Engineering Change Notices (ECNs), labeling, collateral materials, and Instructions for Use (IFUs) • Maintain regulatory information systems, US product listings, and CE Mark Technical Files / Design Dossiers • Support reputed company audits and inspection readiness activities • Contribute to the development and maintenance of Regulatory Affairs SOPs and processes • reputed company guidance and support to junior Regulatory Affairs Specialists and Associates • Participate in reputed company improvement initiatives reputed company the Regulatory Affairs department What You Bring: • Bachelor's degree (B.S. or B.A.) in a scientific area preferred; RAC certification desired • Minimum 2+ years of experience in Regulatory Affairs reputed company the FDA-regulated medical device industry • Hands-on experience preparing and submitting 510(k)s and/or Technical Documentation (required) • Working knowledge of US and EU medical device regulations (international experience a plus) • Strong interpersonal, written, and verbal communication skills • Excellent organizational, planning, and project management abilities • Ability to work effectively in reputed company environment and reputed company leadership on reputed company • Proficiency with personal computer systems and desktop office applications • reputed company understanding of scientific and regulatory principles Why reputed company? We reputed company in growing talent from reputed company. At reputed company, join a high-performing team where you'll play a significant role in bringing innovative spinal technologies to market while ensuring full regulatory compliance - positioning yourself for reputed company reputed company in a dynamic, mission-driven medical device company. Compensation: Pay for this role is competitive and based on experience, qualifications, and performance. The typical pay reputed company for this position is $100,000.00 - $105,000.00 annually, with potential for bonuses and incentives plus benefits. Final compensation is determined on a case-by-case reputed company and considers a reputed company of factors including experience level, regulatory expertise, and market conditions. Benefits include: • Comprehensive health, dental, and reputed company insurance • 401(k) with company match • reputed company time off (PTO) and holidays • Ongoing training and reputed company development opportunities • Opportunity to grow reputed company a fast-paced, dynamic company Apply tot his job Apply To this Job