Regulatory Affairs Specialist

Ampa is a pioneering neurotechnology startup developing brain stimulation technology to help eradicate depression . We will improve millions of lives by making this transformative treatment universally accessible. Joining us means you'll be part of a rapidly growing startup with significant equity opportunities and a major impact on our future.

What to Expect:


Working at Ampa is a rare chance to help transform global mental health and save millions of lives - a level of impact that demands deep commitment. Success here requires resilience, adaptability, and the discipline to put in long hours. If you thrive in a high-intensity, fast-changing environment and want your work to truly matter, you may do the best work of your life here.

Role Overview:

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.

Key Responsibilities:

• Post-Market Regulatory Compliance: Support FDA and global post-market regulatory activities, including change assessments, regulatory impact evaluations, and documentation of regulatory decisions.
• Letters to File and Design Change Assessments: 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.
• Corrections, Removals, and Recall Decisions: Assist with evaluation and documentation of potential corrections, removals, recalls, market actions, and associated reporting obligations.
• Advertising and Promotional Review: Review and approve marketing, sales, website, conference, social media, training, and promotional materials to ensure claims are truthful, supported, and compliant with FDA requirements.
• Complaint and Post-Market Support: Partner with quality, clinical, engineering, and customer-facing teams to assess complaints, adverse events, MDR considerations, field feedback, and post-market surveillance inputs.
• Quality System Support: Assist with CAPAs, nonconformances, supplier quality, risk management updates, document control, internal audits, and audit readiness where regulatory input is needed.
• Cross-Functional Regulatory Guidance: Provide practical regulatory support to engineering, product, clinical, commercial, and operations teams as Ampa implements frequent design and process changes.
• Regulatory Documentation: Maintain clear, audit-ready records supporting regulatory decisions, including rationale for no-submission decisions, promotional approvals, reporting determinations, and quality system records.

What We're Looking For:

Generally

• Mission Obsession: You're passionate about eradicating depression and expanding access to transformative mental health treatment.
• Drive: Highly motivated, open to feedback, and able to learn quickly in a demanding startup environment.
• Adaptability: Thrives in a fast-paced company where priorities change, responsibilities are broad, and documentation must keep up with rapid development.
• Ownership: Comfortable taking responsibility for important regulatory decisions and following through with complete, high-quality documentation.

Specific to this role

• Post-Market Regulatory Judgment: Interest or experience in FDA post-market regulatory work, including letters to file, recall and correction/removal assessments, MDR considerations, labeling, and promotional review.
• Medical Device Regulatory Knowledge: Familiarity with FDA medical device regulations, including 21 CFR Parts 801, 803, 806, 820, and related FDA guidance.
• Quality Systems Experience: Experience with ISO 13485, CAPA, complaints, risk management, internal audits, document control, supplier quality, or design controls is strongly preferred.
• Documentation Discipline: Excellent attention to detail and ability to write clear, defensible regulatory rationales.
• Practical Mindset: Able to balance regulatory compliance with startup speed, using sound judgment rather than excessive bureaucracy.

Experience

• 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.
• Submission Experience: Premarket submission experience is welcome but not required. This role is primarily focused on post-market regulatory support and regulatory-quality decision-making.

Why Join Ampa?

• Impact: Help bring transformative mental health technology to patients who need better treatment options.
• Growth: Build broad regulatory and quality experience in a fast-moving medical device startup.
• Ownership: Take on meaningful responsibility early and directly shape Ampa's regulatory and quality systems.
• Stability: Join a company with a secure product line and a mission-driven team.
• Equity: Receive substantial equity as an early team member.

Logistics:

• Work Mode: In-person
• Location: Palo Alto, CA
• Compensation: $110K to $130K + Strong Equity
• Employment Type: Permanent
• Visa Sponsorship: Will sponsor TN visa or equivalent. No H1B.