Senior Regulatory Specialist

Insight Global; Marietta (GA); Presencial; USD 110.000 - 130.000; Tempo integral

Resumo da vaga

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,

Qualificações

• 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).

Responsabilidades

• 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.

Conhecimentos

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

Formação

Bachelor's degree in science/engineering/regulatory affairs

Descrição da vaga

The Regulatory Specialist will work closely with the Senior Manager of Regulatory and cross-functional business partners to support U.S. product classification, regulatory impact assessments, labeling and marketing reviews, UDI/GTIN activities, FDA device listings, new product development, and M&A initiatives.

This is an excellent opportunity for someone who enjoys working in a fast-paced, growth-oriented environment and wants broad exposure across product regulatory activities.

Key Responsibilities

• Perform U.S. medical device product classifications and determine applicable regulatory requirements.
• Conduct regulatory impact assessments for product, labeling, organizational, and other business changes, including changes associated with 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 Unique Device Identification (UDI) and Global Trade Item Number (GTIN) information.
• Support submission and maintenance of device information within the FDA's Global Unique Device Identification Database (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 cross-functional stakeholders to evaluate regulatory implications and maintain compliance.
• Provide regulatory support for M&A and product integration activities, including assessing regulatory impacts resulting from changes to products, ownership, labeling, or related business activities.
• Maintain documentation in accordance with applicable medical device regulatory and quality-system requirements.
• Support internal or external regulatory and quality audits as needed.

Required Qualifications

• 3-5 years of Regulatory Affairs experience within the medical device industry.
• Strong hands-on experience with Class I medical devices. Candidates with experience across Class II medical devices will also be considered
• Strong working knowledge of applicable FDA medical device regulations and 21 CFR Part 820 / QMSR requirements.
• Working knowledge of ISO 13485 medical device quality management system requirements.
• Experience with product regulatory activities such as:
• Product classification
• Regulatory impact assessments
• Labeling review
• Marketing claims and promotional material review
• UDI/GTIN management
• GUDID activities
• Sustaining regulatory support
• Strong written communication skills and exceptional attention to detail, including the ability to produce accurate, error-free regulatory documentation and communications.
• Bachelor's degree in science, engineering, regulatory affairs, or another relevant field preferred. Equivalent relevant medical device regulatory experience may be considered in lieu of a degree.

Preferred Qualifications

• Working knowledge of ISO 14971 and medical device risk-management principles.
• Experience working in a startup, high-growth, or rapidly changing environment.
• Experience supporting regulatory activities associated with M&A, acquisitions, or product integrations.

This role can pay between 110K-130K + bonus.