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 throughout the product lifecycle. Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.
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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