Senior Medical Device Regulatory Lead

Insight Global; Marietta (GA); On-site; USD 110,000 - 130,000; Full time

Job summary

Insight Global seeks a Regulatory Specialist to support U.S. product classification, labeling, UDI/GTIN, and FDA device listings, collaborating with the Regulatory team and cross-functional partners.

In a fast-paced, growth-oriented environment you will conduct regulatory impact assessments, review marketing materials for compliance, and support updates to registrations, labeling, and launches. The role covers Class I devices (with some Class II), ISO 13485, 21 CFR Part 820, GUDID, and audits,

Qualifications

• 3–5 years of Regulatory Affairs experience in the medical device industry.
• Strong hands-on experience with Class I medical devices; Class II experience considered.
• Working knowledge of FDA medical device regulations and 21 CFR Part 820 / QMSR.
• Working knowledge of ISO 13485 medical device quality management system requirements.
• Experience with product regulatory activities such as: classification, impact assessments, labeling, marketing claims and UDI/GTIN.
• Strong written communication skills and exceptional attention to detail, producing accurate regulatory documentation.
• Bachelor's degree in science, engineering, regulatory affairs, or related field (or equivalent experience).

Responsibilities

• Perform U.S. medical device product classifications and determine applicable regulatory requirements.
• Conduct regulatory impact assessments for product, labeling, organizational, and other changes, including mergers and acquisitions.
• Review product claims, marketing copy, promotional materials, and labeling for regulatory compliance.
• Support product labeling activities and ensure regulatory information is accurate and compliant.
• Manage and maintain UDI and GTIN information.
• Support submission and maintenance of device information within the FDA's GUDID.
• Support FDA device registration and listing activities through FDA systems.
• Provide regulatory support for new product development and product launches.
• Support ongoing sustaining regulatory activities for existing products throughout their lifecycle.
• Partner with Quality, Product Development, Marketing, Operations, and other stakeholders to evaluate regulatory implications and maintain compliance.
• Provide regulatory support for M&A and product integration activities.
• Maintain documentation per medical device regulatory and quality-system requirements.
• Support internal or external regulatory and quality audits as needed.

Skills

Regulatory Affairs

FDA Regulations

21 CFR Part 820

ISO 13485

GUDID/UDI management

Regulatory submissions

Attention to detail

Written communication

Cross-functional collaboration

Medical devices

Education

Bachelor's degree in science/engineering/regulatory affairs

Job description

Insight Global seeks a Regulatory Specialist to support U.S. product classification, labeling, UDI/GTIN, and FDA device listings, collaborating with the Regulatory team and cross-functional partners.

In a fast-paced, growth-oriented environment you will conduct regulatory impact assessments, review marketing materials for compliance, and support updates to registrations, labeling, and launches. The role covers Class I devices (with some Class II), ISO 13485, 21 CFR Part 820, GUDID, and audits,