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Job description
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Base pay range
$50.00/hr - $67.00/hr
Sr. Regulatory Specialist
Fully remote in PST time zone ONLY
Do not apply if you are not currently in a PST time zone
Position summary
We’re hiring a Regulatory Affairs professional with a strong molecular biology background to participate in study design discussions with R&D and author analytical validation study protocols and reports under the guidance of the VP, Quality & Regulatory Affairs. This role is a key contributor to FDA submissions (PMA/510(k)) and requires excellent scientific writing, knowledge of IVD product development requirements, and familiarity with FDA expectations.
Key Responsibilities
Partner with R&D and management to shape analytical validation study designs (e.g., precision/reproducibility, accuracy, LoD/LoB, interference, stability, carryover, controls strategy) and author clear, submission-ready protocols and reports.
Ensure study designs, protocols, and reports align with IVD regulatory expectations (e.g., CLSI EP/MM series, 21 CFR 809, Design Controls, ISO 13485 documentation practices).
Author and maintain high-quality analytical sections for FDA submissions (PMA/510(k)); manage document traceability and alignment to design requirements.
Support Q‑Submission interactions by preparing and organizing analytical documentation and rationales and leverage AI tools.
Collaborate with Quality to route documents through the QMS, address document comments, and maintain a clean DHF and study file record.
Qualifications
Ph.D. in Biomedical Science, Molecular Biology, Biology, Immunology, or related field.
Strong scientific writing skills with a track record of peer‑reviewed publications.
Hands‑on molecular biology lab experience (e.g., PCR/qPCR, NGS library preparation/panels, nucleic acid extraction, reference materials/controls).
Regulatory Affairs experience in IVD and involvement in at least one FDA submission package (PMA or 510(k)).
Working knowledge of IVD product development requirements, CLSI guidance use in validation plans, and documentation under ISO 13485.
Excellent cross‑functional communication and document management skills.
Preferred Qualifications
Regulatory Affairs Certificate
Prior authorship of analytical validation protocols/reports included in a PMA or 510(k).
Experience preparing materials for Q‑Submissions.
Core Competencies
Regulatory literacy for IVDs
Scientific rigor
Technical writing
Collaboration & influence
Document traceability & QMS discipline
What Success Looks Like (first 6 months)
Deliver a fit‑for‑purpose analytical validation protocol suite aligned with product requirements and CLSI/FDA expectations.
Produce submission‑ready analytical reports that integrate cleanly into PMA/510(k) sections.
Support at least one FDA interaction (Q‑Submission/AI) with clear, well‑referenced analytical documentation.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Management, Science, and Quality Assurance
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.