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Clinical Affairs Scientist

Selectek, Inc.
  • Pacheco, CA
  • Instant Apply
1 day ago

Job Description

We seek a highly motivated, scientifically driven Clinical Affairs Scientist to support the development, execution, and communication of clinical research for nutrition, health, and wellness products. This role designs clinical studies, manages research initiatives, analyzes data, and collaborates with cross-functional teams to generate scientific evidence supporting product efficacy, safety, and regulatory compliance.


Responsibilities:
  • Performs IHC, in situ hybridization (ISH), and fluorescence in situ hybridization (FISH) procedures and routine laboratory functions in support of Clinical Affairs and R&D activities.
  • Supports R&D projects and testing activities by preparing and performing studies, documenting results, interpreting experimental data, and contributing scientific conclusions to design and technical documentation.
  • Performs and documents slide grading for R&D and Quality Control (QC), including evaluation of staining quality, specificity, sensitivity, background, morphology, and other applicable performance or acceptance criteria.
  • Conducts systematic scientific and clinical literature searches and reviews; develops and maintains search strategies and evaluates publications for relevance, quality, and applicability to IVD products.
  • Prepares, reviews, and maintains EU IVDR performance evaluation documentation, including but not limited to, Scientific Validity (SV), State of the Art (SOTA), Analytical Performance (AP), Clinical Performance (CP), Performance Evaluation Plans (PEP), and Performance Evaluation Reports (PER), as applicable.
  • Prepares, reviews, and maintains EU IVDR Post-Market Surveillance (PMS) documentation, including PMS Plans, PMS Reports and/or Periodic Safety Update Reports (PSUR), as applicable, and supports periodic evaluation and trending of post-market data.
  • Prepares, reviews, and maintains Post-Market Performance Follow-up (PMPF) documentation, including PMPF Plans and PMPF Evaluation Reports, and supports execution, tracking, and follow-up of PMPF activities.
  • Reviews and scientifically evaluates relevant post-market information, including complaints, customer feedback, vigilance or safety information, published literature, external quality assessment data, and other product performance information in collaboration with QA/RA and other functions.
  • Supports risk management and benefit-risk evaluation by providing scientific, clinical, performance, and post-market evidence and conclusions relevant to assigned products.
  • Writes, reviews, and edits technical documentation for IVD products, including protocols, reports, datasheets, scientific summaries, and other controlled documents requiring scientific expertise.
  • Coordinates participation in NordiQC module testing, performs applicable NordiQC protocols, and supports evaluation and documentation of results.
  • Collaborates with internal cross-functional teams, universities, external laboratories, alpha and beta sites, and other clinical or scientific partners. Some travel may be necessary.
  • Maintains awareness of scientific, clinical, regulatory, and state-of-the-art developments relevant to assigned products; attends applicable seminars, webinars, and workshops and may support abstracts and publications.
  • Reviews test forms and other user-editable or controlled forms of R&D staff members, as assigned, to support scientific accuracy, completeness, and consistency prior to submission or approval.


Required:
  • Primarily focused on scientific writing and grading/reviewing pathology slides.
  • Grading pathology slides and completing associated documentation.
  • Supports testing activities and requires proficiency with microscopes.
  • Strong pathology knowledge preferred.
  • Limited hands-on laboratory work; will work closely alongside laboratory teams.
  • Strong scientific and technical writing skills are critical.
  • Candidates from pharmaceutical, clinical, pathology, or related scientific backgrounds may be applicable.
  • MDR (Medical Device Regulation) experience is relevant and transferable.
  • Regulatory experience preferred, including ICH and tissue morphology-related work.


Preferred:
  • Bachelor's or Master's degree in biochemistry, molecular biology, immunology, oncology, pathology, histotechnology, life sciences, or a related scientific field, with relevant industrial, academic, or clinical laboratory experience. A Ph.D. and/or M.D. in a relevant field is preferred but not required.
  • Experience with IVD products, IHC, scientific or clinical literature evaluation, EU IVDR performance evaluation, PMS/PMPF, and scientific or medical writing is preferred. Certification as a Histotechnologist or other relevant certification by the ASCP is a plus.
  • Strong scientific and technical writing skills with the ability to prepare clear, well-supported, and understandable documentation.
  • Ability to critically evaluate scientific literature, clinical evidence, analytical and clinical performance data, and post-market information.
  • Working knowledge of EU IVDR performance evaluation, PMS, and PMPF concepts and documentation; understanding of ISO 13485, applicable quality system requirements, and GMP principles.
  • Strong knowledge of IHC and staining interpretation, with the ability to consistently grade slides and communicate scientifically sound conclusions.
  • Ability to analyze experimental and post-market data, identify trends or gaps, and translate findings into appropriate scientific documentation and follow-up activities.
  • Adheres to SOPs, quality standards, continual improvement principles, and applicable root cause analysis activities.

                         
 

Numbers & Facts

LocationPacheco, CA

Skills

  • Accounts Payableunmatched
  • Analysis Skillsunmatched
  • Biochemistryunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Clinical Assessmentunmatched
  • Clinical Dataunmatched
  • Clinical Laboratoryunmatched
  • Clinical Pathologyunmatched
  • Clinical Practices/Protocolsunmatched
  • Clinical Researchunmatched
  • Clinical Supportunmatched
  • Clinical Trialunmatched
  • Compensation and Benefitsunmatched
  • Continuous Improvementunmatched
  • Cross-Functionalunmatched
  • Customer/Client Researchunmatched
  • Data Analysisunmatched
  • Datasheetsunmatched
  • Document Managementunmatched
  • Documentationunmatched
  • Documentation Designunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • ICH Regulationsunmatched
  • ISO (International Organization for Standardization)unmatched
  • Immunologyunmatched
  • Laboratoryunmatched
  • Mail Processingunmatched
  • Market Trend Analysisunmatched
  • Medical Equipmentunmatched
  • Medical and Scientific Writingunmatched
  • Molecular Biologyunmatched
  • Nutritionunmatched
  • Oncologyunmatched
  • Pathologyunmatched
  • Performance Analysisunmatched
  • Performance Reviewsunmatched
  • Product Documentationunmatched
  • Product Safetyunmatched
  • Product Supportunmatched
  • Protocol Analysisunmatched
  • Publicationsunmatched
  • Quality Assuranceunmatched
  • Quality Metricsunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Regulatory Complianceunmatched
  • Research & Development (R&D)unmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Safety Complianceunmatched
  • Scientific Publicationsunmatched
  • Standard Operating Procedures (SOP)unmatched
  • State Laws and Regulationsunmatched
  • Strategic Analysisunmatched
  • Support Documentationunmatched
  • Surveillanceunmatched
  • Technical Editingunmatched
  • Technical Writingunmatched
  • Technical/Engineering Designunmatched
  • Trend Analysisunmatched
  • Webinarunmatched
  • Willing to Travelunmatched
  • Writing Skillsunmatched

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