Regulatory Affairs Specialist

Globus Medical • Audubon, PA

13d

About The Position

The Regulatory Affairs Specialist performs regulatory assessments 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. The role reviews product literature and marketing collateral, particularly for Class II devices, to ensure regulatory compliance; monitors and improves tracking and control systems; and stays current on regulatory procedures and changes. The position collaborates across departments and supports regulatory compliance throughout the product lifecycle. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requirements

• Typically requires at least 2 years of related experience with a bachelor’s degree, or 1 year of related experience with a master’s degree, or equivalent work experience.
• Two or more 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.
• Ability to evaluate the regulatory impact of proposed product and process changes.
• Ability to multitask, plan projects, and meet deadlines.
• Results-driven, responsible, urgent, and able to perform under pressure.
• Ability to sit; climb or balance; and stoop, kneel, crouch, or crawl.
• Ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Specific visual abilities, including close, distance, color, and peripheral vision, depth perception, and capacity to adjust focus.

Responsibilities

• Perform regulatory assessments of proposed product changes, including supplier change requests, and document related activities to maintain compliance.
• Apply global regulatory expertise to change assessments in light of local regulations.
• Collaborate with departments to review required plans, procedures, and regulatory decisions for existing products and line extensions.
• Review product literature and marketing collateral, including presentations, advertisements, and social media posts, for regulatory compliance.
• Review technical publications, articles, and abstracts to stay informed about regulatory and technical developments.
• Monitor and improve tracking and control systems and keep abreast of regulatory procedures and changes.
• Follow the company Code of Conduct, the AdvaMed Code, the MedTech Code, and other company policies.
• Complete introductory and annual training and maintain knowledge of applicable governmental laws, rules, and regulations in the United States and internationally.
• Represent the company professionally and uphold ethical business practices and socially responsible conduct in interactions with employees, customers, suppliers, and other third parties.

What This Job Offers

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