Regulatory Affairs Specialist II

SGS Consulting; New York (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

SGS Consulting is seeking a regulatory operations professional to manage RIMS data, develop global GSOPs, and support registrations and UDI activities across multiple jurisdictions.

The role requires experience with regulatory submissions formats, data governance platforms, and dashboards to enable regulatory strategies and KPI reporting. Collaboration across functions will ensure inspection readiness and ongoing compliance.

Qualifications

• Requires knowledge of applicable laws and regulations and staff compliance with them.
• Establishes guidelines and standards for specific tasks.
• Evaluates processes and reviews data and documents for accuracy and consistency.
• Experience authoring and executing SOPs, process documentation, and automation.
• Experience with regulatory data governance platforms and change management systems (e.g., Veeva Vault, Agile).
• Exposure to process automation, dashboards, or analytics (Power BI, Tableau, etc.).
• Familiarity with regulatory submission formats (Estar, eCTD, paper).
• Understanding of FDA regulations and international regulations.

Responsibilities

• Utilize RIMS to manage data accuracy, integrity, and process efficiency; analyze data, manage submissions, uploads, and verifications; generate RIMS reports for regulatory strategies and KPIs.
• Develop and maintain GSOPs, WIs, and controls to support compliance.
• Support device establishment registrations, device listings, and UDI-related activities across global regions.
• Ensure regulatory readiness and inspection-ready documentation across multiple jurisdictions.
• Assist regulatory intelligence, UDI, publishing, and establishment registrations activities.

Skills

Regulatory knowledge

Process guidelines

Data evaluation

SOPs & automation

Regulatory data governance

Dashboards & analytics

Regulatory submissions formats

FDA & international regs

Education

Bachelor’s degree

Tools

Power BI

Tableau

Veeva Vault

Agile

Job description

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.