🚀 Regulatory Affairs Specialist

Medical Devices, Regulatory Affairs Specialist

Burlingame, CA $90,000.00-$137,000.00 2 hours ago

5 days ago Be among the first 25 applicants

Responsibilities

• The Regulatory Affairs Specialist will support regulatory activities for existing US FDA class III medical devices.
• Provide support for currently marketed products, evaluate proposed product and process changes, assess documentation, and provide guidance to ensure regulatory compliance.
• Collaborate with internal stakeholders.
• Prepare and author regulatory submissions and provide critical input on cross‑functional project teams, developing regulatory strategy.
• Support strategy development for US FDA class III medical devices and combination products in the post‑market lifecycle.
• Review product and process changes and conduct regulatory assessments, ensuring appropriate regulatory strategies are communicated to internal stakeholders.
• Conduct risk assessments and recommend mitigation strategies to manage regulatory risks.
• Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices.
• Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g., FDA, ISO, USP).
• Respond to regulatory agencies and coordinate responses with subject matter experts.
• Ensure internal stakeholders are apprised of inquiries from health authorities during the submission approval process according to departmental communication cascades.
• Collaborate with cross‑functional teams (Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met throughout the product lifecycle.
• Maintain regulatory documentation and databases in accordance with company policies, procedures, and department practices.

Requirements

• The ideal candidate is curious, analytical, and a self‑starter, unafraid to ask questions or over‑communicate.
• Bachelor’s degree in a relevant field.
• 4+ years’ experience in the medical device industry.
• 2+ years' direct experience in medical device regulatory affairs, preferably with FDA class III devices.
• Knowledge of Quality Management System standards, including ISO 13485 and ISO 9001.
• Proficiency in MS Office (Excel, PowerPoint, and Word).
• Knowledge of medical device regulations and governing laws such as 21 CFR 814, 21 CFR 820.
• Strong analytical, investigative, and organizational skills.
• Prior experience with PMA Class III devices.

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