Scientist II

SGS Consulting; California City (CA); Sur place; USD 90 000 - 150 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory submissions

Cross-functional collaboration

Project management

Formation

PhD or MS in life sciences

Description du poste

Job Responsibilities

• Regulatory Submission Support:


• Coordinate and deliver timely, informed responses to global regulatory authorities' questions related to assay development and product performance.


• Collaborate cross-functionally with Regulatory Affairs, Quality, and R&D teams to gather and synthesize necessary information for submissions.


• Project Management:


• Track and manage activities and deadlines related to regulatory submissions and post-market support projects.


• Maintain project timelines and communicate status updates to stakeholders.


• Product Knowledge Repository:


• Establish and maintain a comprehensive repository of product knowledge, including technical documentation, study data, protocols, and regulatory correspondence.


• Ensure the repository is organized, accessible, and up-to-date for internal use.


• Documentation Strategy:


• Assess current documentation and design history files for completeness and regulatory readiness.


• Make recommendations and develop strategic plans to address gaps, including proposing new study plans, protocols, and documentation updates.


• Partner with subject matter experts to drive documentation improvements and ensure compliance with global regulatory requirements.

Skills

• 3+ years of experience

Education/Experience

• PhD or MS in life sciences, chemistry, biochemistry, or related field (or equivalent experience).