Regulatory Affairs Specialist II

Job Responsibilities:

• Utilize the Regulatory Information Management System (RIMS) to manage data accuracy, integrity, and process efficiency; perform data analysis and manage submission/document and data uploads and verification; generate RIMS extracted reports to support regulatory strategies, key performance indicators, and blocked orders, etc.
• Develop, maintain, monitor and continuously improve regulatory global standard operating procedures (GSOPs), work instructions, and process controls to support organizational compliance.
• Collaborate and provide cross-functional expertise and support for regulatory operations department requirements such as device establishment registrations, device listings, global unique device identification (UDI) (e.g., FDA GUDID, EUDAMED, AUSUID etc.) and electronic publishing.
• Ensure regulatory readiness, operational efficiency, and inspection-ready documentation across multiple jurisdictions.
• Support regulatory intelligence, UDI, publishing, and establishment registrations activities.

Skills:

• Utilizes knowledge of all applicable laws and regulations that apply to the industry worked in and assures staff members are aware of the legal standards that apply to their work and that they are followed.
• Reviews the processes used in their industry and establishes guidelines and standards for specific tasks.
• Evaluates the processes in place and reviews data and documents.
• Prior experience with authoring and executing standard operating procedures, process documentation, and automation.
• Experience with regulatory data governance platforms and change management systems (e.g., Veeva Vault, Agile, etc.).
• Exposure to process automation, dashboards, or analytics (Power BI, Tableau, etc.).
• Familiarity with regulatory submission formats, including Estar, eCTD, and paper submissions.
• Must possess and demonstrate an understanding of FDA Regulations and international regulations.

Education/Experience:

• bachelor’s degree is required.
• 4–6 years of experience.
• Experienced professional who supports the development and execution of regulatory strategies with a strong focus on global compliance.