Required Skills & Experience
- 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: o Product classification o Regulatory impact assessments o Labeling review o Marketing claims and promotional material review o UDI/GTIN management o GUDID activities o FDA device registration/listing o 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.
Job Description
An Insight Global customer is seeking a Regulatory Specialist to support product regulatory activities across its growing medical device portfolio. This is a hands-on role responsible for ensuring products remain compliant with applicable FDA requirements throughout the product lifecycle, from new product development and commercialization through sustaining activities and organizational changes.
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.
$125,000 to $130,000. - Exact compensation may vary based on several factors, including skills, experience, and education.