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Regulatory Affairs Manager - Leading Orthopedic Company

2.00 to 7.00 Years   Ahmedabad   02 Oct, 2023
PREMIER CONSULTANTS
Job LocationAhmedabad
EducationNot Mentioned
SalaryRs 2.5 - 6 Lakh/Yr
IndustryPharma / Biotech
Functional AreaCorporate Legal Department
EmploymentTypeFull-time

Job Description

    Job opening in leading Orthopedic Company of Regulatory Affairs Manager posisiton at Kheda, AHmedabad.Job Role: Regulatory AffairsLocation: Kheda, AhmedabadJob Roles & Responsibilities:
    • Ability to solve regulatory queries & compliance matters
    • Understanding & knowledge of standards of various international regulatory bodies Updating of relevant SOPs and to conduct training for the same.
    • Keeping abreast with the latest guidelines and regulations.
    • Ensure adherence to deadlines and regulatory compliance
    • Maintaining databases of regulatory submissions
    • Filing/Review of Variation applications
    • Must have knowledge of USFDA audit and previously facing audit of USFDA
    • Planning, Compilation, review and submission of Documents as per Country Specific regulatory guideline in medical device and coordinating with them for registration.
    • Prepare and maintain technical file and medical device master files as necessary to obtain and sustain product approval.
    • Keeping records to documents and samples of different Countries.
    • Co-Ordination with respective departments for Regulatory requirements such as documents (Quality Analysis report, Comparative study report, Validationprotocols and Reports, New product Documents, Samples and Reference Standards etc.)
    • Train staff as and when required on compliance and on other aspects for ISO certifications.
    • Extensive experience in quality assurance and regulatory affairs
    • International registration & communication with regulatory authorities in different country
    • In-process audits for compliance to regulations, protocols and SOPs
    • Manufacturing QA support including thorough review of Batch Manufacturing
    • Clinical investigation, Risk Management etc.
    Essential Requirements:
    • Clinical Evaluation
    • Clinical Assessment
    • Post Market surveillance activity
    • Risk Assessment
    • Risk Management
    • Risk Analysis
    • Risk Management Plan
    • Periodic safety update Report
    • Dossier Preparation of Regulation
    Interested candidates can share there CVs on hidden_email or call on hidden_mobile

Keyskills :
usfdamedical equipmentregulatory compliance

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