Regulatory Affairs Specialist

Company : Katalyst Healthcares & Life Sciences

Responsibilities:

• The Regulatory Affairs Specialist will be responsible for supporting regulatory activities for existing US FDA class III medical devices.
• This role provides support to currently marketed products, involves evaluating proposed product and process changes, assessing documentation and providing guidance to ensure regulatory compliance.
• The Regulatory Affairs Specialist will work collaboratively with internal stakeholders.
• From preparing and authoring regulatory submissions to providing critical input on cross-functional project teams and developing regulatory strategy, this role is an excellent opportunity for the right regulatory professional.
• 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 the appropriate regulatory strategies are communicated to internal stakeholders.
• Conduct risk assessments and provide recommendations to mitigate 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 (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met in throughout the product lifecycle.
• Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.

Requirements:

• The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or over-communicate.
• Bachelor's degree in relevant field.
• 4+ years' experience in 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 814, 21 CFR 820.
• Strong analytical, investigative, and organizational skills.
• Prior experience with PMA Class III devices.

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