Overview
Regulatory Affairs Specialist Jobs in Memphis, TN at GForce Life Sciences
Title: Regulatory Affairs Specialist
Company: GForce Life Sciences
Location: Memphis, TN
Regulatory Affairs Specialist (Medical Devices)
Duration: 6-Month Contract
Location: Remote
Responsibilities
- Support regulatory actions associated with a Legal Manufacturer address change across medical device products.
- Conduct regulatory impact assessments to determine documentation and compliance requirements.
- Review and update medical device labeling, including:
- Instructions for Use (IFUs)
- Product Labels
- Patient Information Leaflets
- Operative Techniques
- Related product documentation
- Review FDA documentation and EU Technical Documentation for compliance with applicable regulations.
- Support regulatory assessments related to changes affecting medical devices.
- Review advertising and promotional materials to ensure regulatory compliance.
- Support CE marking activities and assess the impact of changes on European market compliance.
- Maintain accurate documentation and ensure deliverables are completed within project timelines.
- Collaborate with Regulatory Affairs, Quality, Labeling, and other cross-functional teams.
Qualifications
- 4+ years of experience in the medical device industry.
- 2+ years of experience reviewing medical device labeling, including IFUs, product labels, patient information leaflets, and operative techniques.
- 2+ years of experience working with FDA documentation and EU Technical Documentation.
- 2+ years of experience conducting regulatory assessments for medical device changes.
- 2+ years of experience supporting CE-marked medical devices.
- 2+ years of experience reviewing advertising and promotional materials for regulatory compliance.
- Strong attention to detail and document review skills.
- Strong organizational and time management skills.
- Ability to manage multiple priorities and work independently in a remote environment.
- Experience working within FDA-regulated and EU-regulated medical device environments.
