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

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field (master's preferred).
• Minimum of 8 years of regulatory affairs experience in the medical device industry (preferably Class II/III).
• Demonstrated experience with FDA submissions (510(k), IDE, or PMA) and direct interaction with FDA reviewers.
• Solid understanding of U.S. FDA regulations, QSR (21 CFR Part 820), ISO 13485, ISO 14971, and related standards.
• Excellent written and verbal communication skills in English, with the ability to represent the company professionally before regulatory bodies.

Nice to Have

• Experience with software‑enabled or wearable medical devices.
• Knowledge of EU MDR and international submissions (e.g., Canada, Australia, Japan).
• RAC (U.S.) certification or equivalent professional credential.
• Bilingual (English and Mandarin) a plus but not required.
• Strong problem‑solving, strategic thinking, and organizational skills suitable for a fast‑paced startup environment.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Legal

Industries

Pharmaceutical Manufacturing