Regulatory Affairs Specialist

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions.

Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

Position Summary:

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.

Essential Functions :

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 Adva Med Code, Med Tech 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

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications :

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

Physical Demands :

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

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

Our Values :

Our Life Moves Us philosophy is built on four values:
Passionate About Innovation, Customer Focused, Teamwork, and Driven.

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