Regulatory Affairs Specialist II - Compliance & Data Strategy

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

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.