Regulatory Compliance Specialist

4 weeks ago


Framingham, United States The Judge Group Full time

Our client is currently seeking a Senior Regulatory Compliance Specialist.
This is a permanent, direct hire, on-site role.Responsibilities:Monitor international standards and guide regulatory testing requirements.Support pre-compliance testing for new designs.Collaborate with third-party test houses for compliance testing.Assist with risk analysis and regulatory submissions.Perform other essential duties as assigned.Requirements:10+ years of experience in Class II electro-mechanical medical device development and compliance testing.Knowledge of standards (ISO 14971, IEC 60601 series, etc.) and design controls.Familiarity with EMC/EMI mitigation techniques.Strong proficiency in Microsoft Word and Excel.Bachelor's Degree in a scientific or engineering fieldFor immediate consideration, please email JGood Judge.com.



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