Scientist II

SGS_JOB_3082

Scientific
 California
IVD Molecular Diagnostic Assay Product Development
Assay Development
R&D

Contract - 10 Months + (Possibilities of Contract Extension)

Location : San Diego CA USA 92121 We are seeking a motivated and detail-oriented Scientist II (Senior Scientist equivalent) for a one-year temporary assignment within our R&D Assay Development On-Market Support team..

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).

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