• Regulatory Affairs Specialist

    Requisition ID
    2018-4899
    # of Openings
    1
    Job Location(s)
    Novena Singapore
    Travel
    10-20%
    Education
    Bachelor's Degree
    Position Type
    Full Time
    Expiry Date
    31-7-2018
    Category
    Regulatory Affairs
  • Overview

    • Assist Regulatory Affairs Manager to coordinate and handle regulatory affairs in Singapore.
    • Coordinate and manage timely Regulatory Submissions between local company and our overseas Manufacturers.

    Responsibilities

    • Plan and execute all activities necessary for the product registration
    • Maintain good communication with all manufacturing facilities to obtain support whenever required.
    • Coordinate & implement registration procedure, personally write and review the application documents and submit dossiers for product registration.
    • Maintain QMS (e.g. Good Distribution Practice for Medical Devices, GDPMDS) and implement any changes required including training and communications with affected parties.
    • Negotiate with local authorities on behalf of Company objectives. Act as the key person to communicate and negotiate with local regulatory authorities.
    • Keeping up with local regulatory requirements and inform relevant internal parties on a timely manner.
    • Update our manufacturers for any changes in local regulatory requirement, help them to understand and work with them to provide strategy and multiple options for meeting those regulatory requirements.
    • Handle product complain, reporting adverse events and recall to the local regulatory authorizes as required.
    • Create training materials and train employees to improve regulatory skills in local office or region and at our manufacturers, where applicable
    • Maintain QMS including provision of training to internal staff affected.
    • Learn the Group vision for each regulatory submission and become a trusted leader in the organization
    • Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements

    Qualifications

    • Degree in Science, Engineering or other related discipline.
    • At least 3 years working experience in regulatory field for medical device or pharmaceutical industry would be an advantage, preferably in multinational companies.
    • Experience in negotiating with regulatory authorities.
    • Fluent in English (both spoken and written).
    • Excellent communication and interpersonal skills, able to work with people from different levels internally and externally
    • Excellent time management and organizational skills. Able to perform duties with limit supervision and meet deadline.
    • Skilled in document management.
    • High level of computer skills including Microsoft Office.
    • Multi-tasks and able to prioritize the job tasks, depending on the urgency.
    • Positive attitude, good team player and attention to details.

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