Staftonic LLC ยท 19 hours ago
Regulatory Affairs Specialist
United States
Contract
Remote
Senior Level
6+ years expStaftonic LLC is seeking a Regulatory Affairs Specialist for a long-term project. The role involves defining regulatory classifications, leading compliance efforts for US and EU markets, and coordinating testing and certification with external labs.
Information Technology & Services
Hiring Manager
Shaik Aleem
Responsibilities
Define regulatory classification and document compliance rationale for US and EU markets
Lead CE marking and electrical/safety compliance (UL, IEC, EN standards)
Coordinate testing and certification with external labs
Develop and maintain Declarations of Conformity (DoCs), labeling, and intended-use documentation
Build and maintain compliance documentation for GMP customer audits and qualification
Partner with Engineering, Quality, and Product teams to ensure regulatory requirements are met
Support customer regulatory questionnaires and audit requests
Qualification
Required
6+ years in Regulatory Affairs or Regulatory Compliance in pharma, biotech, or life sciences
Experience with laboratory or analytical instruments and product compliance
Knowledge of US and EU regulations for non-IVD, non-medical lab equipment
Hands-on experience with CE marking and safety standards (UL, IEC, EN)
Experience with DoCs, labeling, and intended-use documentation
Familiarity with GMP audit and customer qualification requirements
Strong documentation and communication skills
Company
Staftonic LLC
At Staftonic, we believe in turning possibilities into realities.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase