Joulé · 10 hours ago
Senior Analyst, RAQA Compliance - Individual Contributor
United States
Contract
Remote
Mid, Senior Level
2+ years expJoulé is seeking a Regulatory Affairs Specialist to support regulatory compliance activities by preparing assessments and submissions required for product clearances and approvals. This role will serve as a regulatory resource to project teams, ensuring that regulatory requirements are understood and executed accurately.
Responsibilities
Prepare and manage regulatory assessments, documentation, and submissions to FDA, Notified Bodies, and other regulatory authorities
Apply regulatory and legal frameworks, requirements, and procedures to support product clearances and approvals
Coordinate and execute regulatory deliverables, including writing, project tracking, and cross-functional alignment
Complete technical and scientific regulatory assignments that support product development and compliance objectives
Provide regulatory guidance to project teams as a subject matter resource
Communicate status, risks, and outcomes to supervisors and senior regulatory staff as appropriate
Exercise independent judgment on routine regulatory matters and escalate complex issues when needed
Qualification
Required
Bachelor's degree (B.S. or B.A.) in Engineering, Science, or a related field
2–3 years of experience in an FDA-regulated industry
Working knowledge of regulatory requirements and submission processes
Ability to manage regulatory tasks independently with minimal supervision
Preferred
RAC certification or a master's degree in Regulatory Affairs
Benefits
Health and welfare benefits coverage options
Medical
Dental
Vision
Spending accounts
Life insurance
Voluntary plans
Participation in a 401(k) plan
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase