Regulatory Affairs Specialist

Globus Medical • Audubon, PA

6d

About The Position

Performs a thorough regulatory assessment for proposed changes to current products and provides Regulatory support for line extensions and supplier change requests, ensuring compliance with local and regional registration requirements. Conducts an in-depth review of product literature and marketing collateral for all products, with an emphasis on Class II devices, to ensure Regulatory compliance. Monitors and improves tracking and control systems. Keeps abreast of regulatory procedures and changes.

Requirements

• Typically requires a minimum of 2 years of related experience with a Bachelor’s degree; or 1 year and a Master’s degree; or equivalent work experience
• Two+ 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

• Performs a through regulatory assessment for proposed product changes, including supplier request changes and documents all related activates to remain in compliance
• Demonstrates global regulatory expertise for change assessments with local regulations
• Collaborates with various departments to review the required plans, procedures and regulatory decisions for existing products or line extensions
• Conducts review of product literature and other marketing collateral (presentations, advertisements, social media posts, etc.) to ensure Regulatory compliance
• Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry
• 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 this role
• Represents the company in a professional manner and upholds 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: Mid Level