Senior Regulatory Affairs Specialist - Medical Devices

Kelly Services; Goose Creek (SC); On-site; USD 95,000 - 140,000; Full time

Job summary

Kelly Science is seeking an experienced Regulatory Affairs Specialist to support regulatory strategy, submissions, and ongoing compliance for a medical device organization in Goose Creek, SC. The role targets hands‑on professionals with 5–10+ years of regulatory experience for Class II/III devices across the product lifecycle.

Responsibilities include developing regulatory pathways, preparing submissions, maintaining technical documentation, and ensuring adherence to 21 CFR Part 820, ISO 13485,

Qualifications

• 5–10+ years of regulatory affairs experience in medical devices.
• Experience with FDA‑regulated devices and US regulatory requirements.
• Experience supporting Class II and Class III submissions.
• Knowledge of 21 CFR Part 820, ISO 13485 and ISO 9001.

Responsibilities

• Support regulatory strategy and pathway development for new and existing devices.
• Prepare and maintain regulatory submissions for FDA and other authorities.
• Support FDA submissions for Class II and III devices.
• Collaborate with cross‑functional teams to incorporate regulatory requirements.
• Ensure compliance with FDA regulations and quality system requirements.
• Monitor regulatory changes and assess impacts to projects.
• Support audits, CAPA, change assessments, and lifecycle activities.

Skills

Regulatory affairs

FDA regulations

Technical writing

Project management

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Regulatory Affairs degree

Job description

Kelly Science is seeking an experienced Regulatory Affairs Specialist to support regulatory strategy, submissions, and ongoing compliance for a medical device organization in Goose Creek, SC. The role targets hands‑on professionals with 5–10+ years of regulatory experience for Class II/III devices across the product lifecycle.

Responsibilities include developing regulatory pathways, preparing submissions, maintaining technical documentation, and ensuring adherence to 21 CFR Part 820, ISO 13485,