Regulatory Compliance Specialist (Med Device)

The Judge Group
Framingham, MA
$140K a year
Permanent

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, and design controls.
  • Familiarity with EMC / EMI mitigation techniques.
  • Strong proficiency in Microsoft Word and Excel.
  • Bachelor’s Degree in a scientific or engineering field

For immediate consideration, please email

30+ days ago
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