More jobs:
Scientist II
Job in
California City, Kern County, California, 93504, USA
Listed on 2026-10-18
Listing for:
SGS Consulting
Full Time
position Listed on 2026-10-18
Job specializations:
-
Science
Medical Science Liaison, Research Scientist
Job Description & How to Apply Below
- 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.
- 3+ years of experience
- PhD or MS in life sciences, chemistry, biochemistry, or related field (or equivalent experience).
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