Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - Ethicon, Inc. - Cincinnati Ohio

Company: Disability Solutions
Location: Cincinnati, Ohio
Posted On: 05/08/2024

Robotics & Digital Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Specialist . The preferred location for this role is within a commutable distance of Cincinnati, OH however candidates within commutable distance of Santa Clara, CA or Raritan, NJ will also be considered . This role will work a Flex/Hybrid schedule with 3 days per week on-site. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at In joining our growing regulatory team, the Sr. Regulatory Affairs Specialist will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will be working on the robotics, instruments and accessories portfolio RA needs, working closely with exceptional engineering and clinical teams, as well as supporting product development stages and generating submission ready documentation and authoring regulatory submissions. Additionally, this individual will support health authority communications and participate in strategy development. Key Responsibilities : --- Applies strategic regulatory thinking along with technical expertise to implement regulatory strategies for new product clearances and approvals. --- Prepares and submits regulatory information required to obtain global market access including preparation, writing and filing of FDA submissions including 510(k)s and global health authorities' submissions technical documents. --- Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status. --- Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. --- Assists in the development of Regulatory Affairs processes. The base pay range for this position is $90,000 to $130,000 ($105,000 to $150,000 for candidates in Santa Clara ) based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. More...

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