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. The ideal candidate will be curious, analytical and a self-starter, unafraid to ask questions or over-communicate. 1 Regulatory strategy • Support strategy development for US FDA class III medical devices and combination products in the post-market lifecycle. 2 Regulatory assessments • 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. 3 Regulatory submissions • Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices. 4 Regulatory compliance • Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g. FDA, ISO, USP). 5 Regulatory interface and communication • 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. 6 Cross-functional collaboration • Collaborate with cross-functional teams (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met in throughout the product lifecycle. 7 Document management • Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices....diploma or equivalent. Previous experience in data entry or administrative roles is a plus. Proficiency in Microsoft Office (Excel, Word) and Google Workspace. Excellent typing speed and accuracy. Strong attention to detail and organizational skills. Reliable...
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