Regulatory Affairs Specialist – MedTech Compliance

Globus-Medical; Lower Providence Township (PA); On-site; USD 70,000 - 100,000; Full time

Job summary

Globus Medical seeks a Regulatory Affairs professional to perform thorough regulatory assessments for proposed product changes and support line extensions. You will review literature and marketing collateral to ensure compliance with US and international regulations, and collaborate with multiple departments to align plans and regulatory decisions.

The role requires 2+ years in medical devices, a Bachelor’s degree (or equivalent with Master’s), and a solid understanding of pre-market submission

Qualifications

• Bachelor’s degree required; or 1 year and a Master’s degree; or equivalent work experience.
• 2+ years of related experience in the medical device industry.
• Solid understanding of regulatory terminology and submission types.
• Able to evaluate regulatory impact of proposed product and process changes.

Responsibilities

• Performs regulatory assessment for proposed product changes, including supplier request changes.
• Demonstrates global regulatory expertise for change assessments with local regulations.
• Collaborates with departments to review plans and regulatory decisions for products or line extensions.
• Reviews product literature and marketing collateral to ensure regulatory compliance.

Skills

Regulatory knowledge

Pre-market submissions

Project planning

Multi-tasking

Deadline management

Communication

Education

Bachelor’s degree

Master’s degree

Job description

Globus Medical seeks a Regulatory Affairs professional to perform thorough regulatory assessments for proposed product changes and support line extensions. You will review literature and marketing collateral to ensure compliance with US and international regulations, and collaborate with multiple departments to align plans and regulatory decisions.

The role requires 2+ years in medical devices, a Bachelor’s degree (or equivalent with Master’s), and a solid understanding of pre-market submission