Position Summary

The primary responsibility of the regulatory manager is to manage and perform regulatory submissions for local and worldwide regulatory agencies. The RA manager is also responsible for ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for 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 ghd organization as well as regulatory bodies.

Duties and Responsibilities:

• Develops strategies and implements plans to obtain FDA Approvals, CE Mark and other foreign regulatory approvals.

• Manage and prepare regulatory submissions and registrations (FDA and EU regulatory entities)

• Oversee IDE, PMA, 510(k), EU MDR, and other regulatory filings.

• Maintain regulatory Technical Files, Device Master Records, Essential Requirements Checklist, Risk Analysis, and Design History Files.

• Review changes to 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.

• Represent Regulatory Affairs on Engineering & R&D product development project teams to ensure all regulatory requirements are met throughout the development process.

• Perform additional duties as required

JOB QUALIFICATION REQUIREMENTS

• Bachelor’s degree (B.S.) from four-year College or University.

• Two (2) years minimum experience in regulatory affairs.

• Current knowledge of FDA Guidelines, Medical Device Directives (93/42/EC), ISO 13485, and standards applicable to company 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.