Regulatory Affairs Specialist
2 weeks ago
Position Summary
The primary responsibility of the Regulatory Affairs Specialist is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The RAS is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for our client's product market entry and maintenance. The position requires a high level of innovative thought and problem-solving skills. Multiple tasks will need to be prioritized and responsibilities delegated to ensure department success. In addition to the above responsibilities, the regulatory specialist is required to interact with multiple departments within our client's organization as well as regulatory bodies.
Duties and Responsibilities:
Develops strategies and implements plans to obtain regulatory approvals for our client. (e.g., FDA Approvals, CE Mark)
Prepare regulatory submissions and registrations for our client. (e.g., FDA and EU regulatory entities)
Support IDE, PMA, 510(k), Design Dossiers, Technical Files, and other regulatory filings for our client.
Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files for our client.
Review changes to our client's Existing Products, SOPs, DOPs, Test Methods, Process Changes, Design Changes, Labeling/Labels, and Field issues to define the requirements for regulatory submissions and notifications.
Support communication with FDA and Notified Body representative while preparing responses to deficiency letters and/or questions from regulatory agencies on behalf of our client.
Represent Regulatory Affairs on Engineering & R&D product development project teams for our client to ensure all regulatory requirements are met throughout the development process.
Perform additional duties as required.
REPORTING
This position will report directly to the VP, Quality and Regulatory Affairs. Our client's specific duties will be determined and coordinated in conjunction with the corporate needs and strategic plans and will be subject to change given ongoing business and clinical research needs.
JOB QUALIFICATION REQUIREMENTS
Bachelor’s degree (B.S.) from four-year College or University.
Three (3) years minimum experience in regulatory affairs.
Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to our client's products.
Knowledge and understanding of Quality and Regulatory concepts and application * Strong analytical, planning and organizational skills * Strong interpersonal and communications skills (oral & written)
Self-starter with ability to work independently under pressure and react quickly to changing priorities
Proficient in MS Office products.
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