Regulatory Affairs Specialist

Ampa•Palo Alto, CA

1d•Onsite

About The Position

Ampa is seeking a highly detail-oriented Regulatory Affairs Specialist to support our post-market regulatory activities and ensure our neurostimulation systems remain compliant as the company grows. This role is focused less on traditional premarket submissions and more on the practical regulatory work required to operate responsibly after product clearance, including regulatory assessments for design changes, letters to file, recalls, corrections and removals, advertising and promotional review, complaint-related regulatory decisions, and ongoing compliance with FDA and global requirements. The ideal candidate is someone who enjoys careful regulatory reasoning, strong documentation, and cross-functional collaboration. Experience in quality systems is a strong plus, especially in a medical device startup environment where regulatory and quality work often overlap.

Requirements

Bachelor’s degree in engineering, life sciences, regulatory affairs, quality, or a related field.
5+ years of experience in medical device regulatory affairs or a related role.
Familiarity with FDA medical device regulations, including 21 CFR Parts 801, 803, 806, 820, and related FDA guidance.
Excellent attention to detail and ability to write clear, defensible regulatory rationales.
Able to balance regulatory compliance with startup speed, using sound judgment rather than excessive bureaucracy.

Nice To Haves

Experience in quality systems is a strong plus, especially in a medical device startup environment where regulatory and quality work often overlap.
Experience with ISO 13485, CAPA, complaints, risk management, internal audits, document control, supplier quality, or design controls is strongly preferred.
Premarket submission experience is welcome but not required.

Responsibilities

Support FDA and global post-market regulatory activities, including change assessments, regulatory impact evaluations, and documentation of regulatory decisions.
Evaluate product, process, labeling, software, and manufacturing changes to determine whether they require regulatory submission, letter to file, risk documentation updates, or other regulatory action.
Assist with evaluation and documentation of potential corrections, removals, recalls, market actions, and associated reporting obligations.
Review and approve marketing, sales, website, conference, social media, training, and promotional materials to ensure claims are truthful, supported, and compliant with FDA requirements.
Partner with quality, clinical, engineering, and customer-facing teams to assess complaints, adverse events, MDR considerations, field feedback, and post-market surveillance inputs.
Assist with CAPAs, nonconformances, supplier quality, risk management updates, document control, internal audits, and audit readiness where regulatory input is needed.
Provide practical regulatory support to engineering, product, clinical, commercial, and operations teams as Ampa implements frequent design and process changes.
Maintain clear, audit-ready records supporting regulatory decisions, including rationale for no-submission decisions, promotional approvals, reporting determinations, and quality system records.