Katalyst CRO
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.
Get notified about new Regulatory Affairs Specialist jobs in
San Francisco, CA .
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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.
Get notified about new Regulatory Affairs Specialist jobs in
San Francisco, CA .
#J-18808-Ljbffr