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
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Our client is currently seeking a Senior Regulatory Compliance Specialist. Class II electro-mechanical medical device development and compliance testing. Monitor international standards and guide regulatory testing requirements. Support pre-compliance testing for new designs. ...
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