What are the responsibilities and job description for the Regulatory Compliance Engineer/ Medical Device Compliance Engineer position at Intellectt Inc?
Role: Codes & Standard Engineer / Regulatory Compliance Engineer/ Medical Device Compliance Engineer
Location: Raleigh, NC- Onsite
Description & Skill Requirement:Analy
- ze design documents, specifications, and risk assessments to identify potential safety and performance issues related to device design and functionality.Parti
- cipate in risk management processes, identifying potential hazards, analyzing their severity, and implementing appropriate mitigation strategies.Stay
- updated on regulatory changes and advise cross-functional teams on necessary adjustments to maintain compliance with applicable regulations (FDA, CE Marking, etc.)Desig
- n testing for UL requirements and certifications and CSA/EU 60601 standards certification.Hospi
- tal BED standards for UL certification and FDA regulations.10DFM
- E, Risk assessment. Single fault analysisESD c
- ontrols, ESD Procedure for ISO audit controls compliance.Exper
- ience in a NRTL test house would be greata.Set
- ting up for FCC part 15 testingb.Set
- ting up and performing ESD testingc.Set
- ting up for Environmental testingQuali
fication:BS/MS
degree
