Regulatory Submissions Scientist II – Impact & Strategy

SGS Consulting; California City (CA); On-site; USD 90,000 - 150,000; Full time

Job summary

SGS Consulting is seeking a regulatory affairs professional to lead submission activities and manage responses to global authorities related to assay development and product performance. You will work across Regulatory Affairs, Quality and R&D to assemble the necessary information and ensure timeliness.

In this role you will oversee project timelines for submissions and post-market support, maintain a comprehensive product knowledge repository, and develop strategy to address gaps in

Qualifications

• 3+ years of experience in regulatory affairs or related field.
• Experience coordinating regulatory submissions.
• Ability to synthesize data for submissions.

Responsibilities

• Coordinate regulatory submissions and respond to global authorities.
• Collaborate with Regulatory Affairs, Quality and R&D to gather data.
• Track activities and deadlines for submissions and post-market work.
• Maintain timelines and provide status updates to stakeholders.
• Build and maintain a product knowledge repository.
• Ensure docs are organized, accessible, and up-to-date.
• Assess docs and design history files for regulatory readiness.
• Propose study plans and documentation updates to close gaps.

Skills

Regulatory submissions

Cross-functional collaboration

Project management

Education

PhD or MS in life sciences

Job description

SGS Consulting is seeking a regulatory affairs professional to lead submission activities and manage responses to global authorities related to assay development and product performance. You will work across Regulatory Affairs, Quality and R&D to assemble the necessary information and ensure timeliness.

In this role you will oversee project timelines for submissions and post-market support, maintain a comprehensive product knowledge repository, and develop strategy to address gaps in