MedTech Global Regulatory Affairs Specialist

NML Medical; Pennsylvania; On-site; USD 90,000 - 120,000; Full time

Job summary

Globus Medical is seeking a Regulatory Affairs professional to perform comprehensive regulatory assessments for proposed product changes and provide support for line extensions and supplier requests. The role emphasizes ensuring compliance with US and international requirements and staying ahead of regulatory developments to drive lifecycle success.

Ideal candidates bring 2+ years in medical devices, strong knowledge of pre-market submissions, and a disciplined, deadline-driven approach to

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

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

Skills

Regulatory knowledge

Regulatory terminology

Product lifecycle

Pre-market submissions

Multi-tasking

Urgency and accountability

Education

Bachelor's degree

Master's degree

Job description

Globus Medical is seeking a Regulatory Affairs professional to perform comprehensive regulatory assessments for proposed product changes and provide support for line extensions and supplier requests. The role emphasizes ensuring compliance with US and international requirements and staying ahead of regulatory developments to drive lifecycle success.

Ideal candidates bring 2+ years in medical devices, strong knowledge of pre-market submissions, and a disciplined, deadline-driven approach to