»Regulatory Affairs

    Highlights

    Ensures compliance with ISO and Applicable regulatory requirements and Council of European Communities Regulations for medical devices. Coordinates & Conducting awareness of applicable regulatory and quality management requirement throughout the organization.

    Numbers & Facts

    LocationCA

    Description

    • Designation: Regulatory Affairs
    • Experienced: Fresher or 2-5 years
    • Qualification: Mechanical Engineer, B.Pharm and M.Pharm
    • Location: Mumbai (Kandivali)

    Send us your CV E-mail : hr@allwinmedical.com

    • Contact on : +91 93138 07505

    Job Description :

    Defines and documents quality management system.

    Implements quality management system throughout the organization

    maintains, and continually improves the effectiveness of the quality system

    Manage validation program

    Manage calibration program

    Maintains and controls quality documents and quality records (i.e., procedures, DHR's, etc.)

    Coordinates corrective and preventive action process

    Ensures compliance with ISO and Applicable regulatory requirements and Council of European Communities Regulations for medical devices

    Manages customer complaint/feedback system

    Maintains internal and external quality audit records

    Final product disposition

    Quality control function in lab and sterilization area

    Verification and validation of manufacturing processes

    Coordinates & Conducting awareness of applicable regulatory and quality management requirement throughout the organization

    Defining the sequence and interaction between processes

    Conducting management review meeting

    Reporting the performance of a quality system to management for review and provide information for improvement.

    Desired candidate profile requirement:

    • Proficient communication skills and relationship building skills
    • Interpersonal skills
    • Computer survey with good knowledge of excel
    • Dynamic and hardworking
    • Ability to influence and negotiate.
    • Hardworking & creative nature.
    • Immediate starters

    Interested candidates send their resume to hr@allwinmedical.com or fill in the Career form.

    Contact on : +91 93138 07505

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