Regulatory Affairs Specialist (1 year contract)
Core
Coordinates regulatory submissions, license renewals, and interactions with agencies to ensure compliance for medical technologies.
Role type
Specialist Regulatory Affairs Specialist
Builds
Regulatory document packages, submission materials, and compliance strategies for clinical trials and product approvals.
Domain
Healthcare technology / Medical devices
Deliverable
client delivery
Required skills
Regulatory submission coordination, license renewal management, labeling and manufacturing compliance, clinical protocol compliance, regulatory tracking systems, agency interaction, clinical trial application strategy
Preferred skills
Advanced education in relevant field, experience with regulatory procedures
Technologies
Regulatory tracking systems
Responsibilities
Directs or performs coordination of regulatory submission documents; Compiles materials for submissions and license renewals; Recommends changes for labeling, manufacturing, and clinical protocols; Monitors tracking and control systems; Interacts with regulatory agencies; Recommends strategies for early clinical trial approvals
Seniority
Specialist, individual contributor with project delivery focus