Sr Regulatory Affairs Specialist

Position Summary

Captures and prepares document packages for regulatory submissions for new and mature products, ensuring compliance with local and regional registration requirements. Compiles all materials required in submissions, license renewal, and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocols for regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications.

Essential Functions

• Determines the appropriate regulatory strategy for new products and documents all related activities to remain in compliance.
• Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations.
• Collaborates with various departments to review required plans, procedures, and regulatory decisions for new or existing products.
• Reviews regulatory requirements from other departments for new product designs or changes to existing designs.
• Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
• Prepares and maintains regulatory pre-market submissions and other pre-market filings to assist in acquiring appropriate commercial distribution clearances.
• Supports product import by providing applicable regulatory documentation and certificates.
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
• Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.

Qualifications

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree.
• Solid understanding of regulatory requirements throughout the product lifecycle.
• Strong understanding of regulatory terminology, pre-market submission types, and requirements.
• Able to evaluate regulatory impact of proposed product and process changes.
• Capable multi-tasking skills with the ability to project plan and meet deadlines.
• Result-driven with a sense of responsibility, urgency, and ability to perform under pressure.

Physical Demands

• Required to sit; climb or balance; and stoop, kneel, crouch, or crawl.
• Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds.
• Required to possess specific visual abilities, including close vision, distance vision, color vision, peripheral vision, depth perception, and capacity to adjust focus.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.