Regulatory Affairs Specialist II

SGS Consulting; Williamstown (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

SGS Consulting is seeking a Regulatory Operations Specialist to manage RIMS data accuracy, support submissions, and drive global compliance initiatives. The role emphasizes collaboration across regulatory functions for device registrations and UDI management.

The candidate will develop GSOPs, maintain documentation, and ensure inspection-ready records across multiple jurisdictions, while supporting regulatory intelligence and publishing activities.

Qualifications

• 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.

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

RIMS data management

Data analysis

Regulatory submissions

Documentation & uploads

GSOPs & SOPs

Regulatory governance

Veeva Vault / Agile

Power BI / Tableau

FDA & international regs

Cross-functional collaboration

Education

Bachelor's degree

4–6 years experience

Tools

Veeva Vault

Agile

Power BI

Tableau

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.