Senior Regulatory Specialist

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This range is provided by Planet Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

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