senior qa/ra executive - Delhi, India - GPC Medical Ltd.

    GPC Medical Ltd.
    GPC Medical Ltd. Delhi, India

    2 weeks ago

    Default job background
    Upper Management / Consulting
    Description

    Company Description

    GPC Medical Ltd. is an Indian hospital and medical supplies company with decades of experience supplying high-quality medical equipment and orthopedic implants/instruments all over the globe. The company is ISO 13485 Certified, WHO-GMP Compliant, and many of its products are CE Marked. GPC Medical specializes in Orthopedic Implants, Medical Disposables, Hospital Furniture & Autoclave Sterilizers, and its products are supplied to almost all European countries.

    Role Description

    This is a full-time on-site role as a Senior QA/RA Executive located in New Delhi. As a Senior QA/RA Executive, you will be responsible for ensuring compliance with regulatory requirements and managing regulatory submissions at GPC Medical.

    Roles and Responsibilities

    · Proficient in drafting and evaluating documents in accordance with ISO 13485, EU-MDR, 21CFR820, Thai FDA, and Indian Medical Device Regulations, ensuring their effective implementation.


    • Compile regulatory documents (TMF/Dossiers) for submission.


    • Create Design files adhering to ISO 13485:2016, MDR, and USFDA standards.


    • Manage adverse event reporting to EU and other regulatory agencies.


    • Expertise in developing and updating risk management and usability evaluations compliant with ISO 14971 and IEC


    • Skilled in preparing and revising PMS, PMCF, PSUR, and clinical evaluation files, aligned with Regulation (EU) 2017/745.


    • Extensive knowledge of process and equipment qualification and validation.

    Qualifications

    • Expertise in regulatory compliance and regulatory affairs management
    • Ability to interpret and apply regulatory requirements.
    • Experience in managing regulatory submissions.
    • Strong knowledge of quality system regulations and standards
    • Excellent written and verbal communication skills
    • Bachelor's degree in regulatory affairs, science, engineering, or related field
    • Master's or other advanced degree in regulatory affairs or related field is a plus.

    Experience

    5-6 years' experience in a similar role.

    Industry

    • Medical Equipment Manufacturing

    Employment Type

    Full-time