Regulatory Affairs Manager

Quality Assurance & Regulatory Affairs Manager, San Francisco, CA

$100,000 - $150,000, 3 weeks ago

Responsibilities

• Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements.
• Serve as the primary point of contact with the U.S. Food and Drug Administration (FDA) and their regulatory agencies, leading meetings, Q-Subs, and communications.
• Collaborate with cross‑functional teams (R&D, Clinical, QA, Manufacturing) to align regulatory strategies with product design, testing, and commercialization plans.
• Prepare, review, and manage regulatory submissions, technical files, and design dossiers for U.S. and global markets.
• Interpret and communicate regulatory requirements, guidance, and changes (e.g., 21 CFR Parts 807, 812, 814, 820; ISO 13485; ISO 14971; MDR).
• Ensure labelling, advertising, and promotional materials comply with FDA regulations and company policies.
• Support quality and clinical teams in pre‑submission meetings, audits, and inspections.
• Monitor evolving U.S. and international regulatory landscapes, providing proactive recommendations to management.
• Develop and maintain relationships with regulatory consultants, testing labs, and external partners.
• Provide regulatory training and mentoring to internal stakeholders.

Requirements

Nice to Have

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Legal

Industries

Pharmaceutical Manufacturing

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