IT - Risk Management
- Systechcorp Inc
- 2 - 6 years
- Kolkata
- 2 months ago
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Job Description
Job Description: IB - Regulatory Engineer The team developing industry leading X-ray generation subsystems is looking for highly motivated regulatory engineers to join them in ensuring compliance and availability of these subsystems for CT scanners to all the global markets of interest.
Regulatory Engineer will be working on compliance activities for various medical devices global regulations. Responsibilities
Collaborate with cross functional teams (engineering, manufacturing, regulatory, sourcing, etc.) to lead or support compliance activities to medical device regulations.
Review regulatory compliance change notifications and drive associated actions to be compliant by the effective date
Lead compliance efforts to various global regulations (E.g. REACH, ROHS, etc.) in alignment with the quality management system
Lead or support product regulatory documentation updates (e.g. NRTL reports, tech file, etc.)
Support regulatory audits and inspections to ensure post-market surveillance compliance. Qualifications we seek in you!
Minimum Qualifications
Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations
Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.
Proficiency in interpreting, applying complex regulations, and preparing associated documentation.
Excellent interpersonal communication and collaboration skills
Bachelor s degree in engineering, Science or related area
Minimum of 2 years of experience working with medical devices regulations and quality management system.
proficiency with written English and with neutral English accent Preferred Qualifications/ Skills
Strong technical knowledge
Effective probing skills and analyzing / understanding skills
Strong attention to detail.
Job Classification
Industry: IT Services & ConsultingFunctional Area / Department: Risk Management & ComplianceRole Category: Risk Management & Compliance - OtherRole: Risk Management & Compliance - OtherEmployement Type: Full timeContact Details:
Company: Systechcorp IncLocation(s): Kolkata+ View Contact
Keyskills: Medical devices ISO 13485 QMS Team development IT risk management Regulatory compliance system lead ROHS Auditing
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Systechcorp Inc
SysTechCorp Inc provides leading-edge technology services that empower our clients to meet and exceed their strategic business objectives. Our AI, ML, Mobile, Cloud, and ERP practice is backed by years of experience and deep domain expertise in a wide range of industry verticals.
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