Sr Regulatory Affairs Specialist

Globus Medical • Audubon, PA

8d

About The Position

Coordinates 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 protocol 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.

Requirements

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience
• 5+ years of related experience in the medical device industry
• Understanding of regulatory requirements throughout the product lifecycle
• Solid 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

Responsibilities

• Determines the appropriate regulatory strategy for new products and documents all related activates to remain in compliance
• Demonstrates global regulatory expertise in product submissions and evaluates changes with local regulations
• Collaborates with various departments to review the 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior