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

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