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  • Regulatory Analyst with Medical Devices Industry Experience


    Job Title: Regulatory and Requirements Analyst with Medical Devices Industry Experience

    Report to: Global Regulatory and Requirements Team Manager

    Location: Cork, Ireland

    Purpose:

    Compliance and Risks is an Irish-owned, end-to-end regulatory solutions company helping manufacturers, retailers and their supply chain partners to monitor and manage regulatory developments globally.

    As a Regulatory & Requirements Analyst, with Medical Devices industry experience you will be working as part of our Global Regulatory & Requirements Compliance Team (GRCT). The GRCT is responsible for monitoring global regulatory & requirements developments, both enacted and proposed, as well as supporting information, such as guidance documents, across a wide range of topics, from product safety to WEEE, RoHS, occupational health & safety and many more.

    Main responsibilities include monitoring regulatory & requirements developments globally and entering the information into our online database C2P, in a structured format, providing an overview of the regulatory information and identifying key details such as when the measure enters into force & upcoming compliance deadlines.

    Requirements (extracted from Regulations and Standards) are entered into the Requirements Management Platform within C2P in response to business & client needs.

    Key Responsibility Areas:

    Monitoring

    • Monitor regulatory developments for specified countries
    • Also specifically research, monitor, and maintain global regulatory requirements that are set out in Regulations and Standards in C2P on a wide range of topics that are live-linked to Regulations, Standards and all other requirements, allowing for easy revisions and tracking
    • Own, maintain and enhance ‘monitoring issues’ for specified countries, ensuring sources of regulatory information & any additional useful information to aid monitoring is recorded and current
    • Utilize automatic monitoring tools to maximize the efficient and prompt capture of regulatory information

    Entry of Regulatory Information into C2P & Requirements Platform

    • Enter regulatory and supporting sources into C2P in line with established data entry conventions
    • Ensure all information uploaded is accurate & exhibits a keen attention to detail
    • For Regulations, drafting of clear, well written, accurate summaries on key details in text, underpinned with an appreciation of clients’ needs
    • Addition of regulatory updates concerning regulatory developments to C2P
    • Review of daily email alerts via C2P on regulatory changes to existing Regulations and Standards to determine if new Requirements need to be added to Platform or existing Requirements should be updated
    • Monitor regulatory developments for specified countries and product groups/categories via Regulatory Update and Expert Comments received via C2P alerts, ‘watching’ various C2P projects as well as various other online monitoring tools
    • Ensure a comprehensive and reliable bank of sources of regulatory information is built up and maintained to ensure effective and optimal monitoring for responsible countries and product groups/categories
    • Utilize automatic monitoring tools to maximize the efficient and prompt capture of regulatory information

    Research

    • Conduct research on assigned tasks such as researching new areas of coverage being expanded into or client specific projects
    • Utilize a wide variety of research databases and online resources

    Database Content

    • Possess a knowledge and understanding of all areas of coverage in the C2P database and Requirements Platform

    Process Improvements

    • Work with your Team Manager in identifying potential improvements / changes to the C2P or Requirements Platform
    • Add value to the development of quality control processes to ensure the accuracy, comprehensivity and reliability of the information
    • Actively engage in ongoing changes to the team’s processes in order to improve team efficiency as well as pro-actively contributing ideas and suggestions for improvement. This will involve active participation in establishment and maintenance of monitoring procedures and data entry conventions for the team

    Prior Experience & Qualifications:

    • Degree in Law. Postgraduate or Masters in Law desirable. Other degrees may be considered if the candidate has strong research, writing and language skills
    • Experienced researcher
    • Knowledge of the global Medical Devices industry
    • Knowledge of other environmental/product compliance regulations desirable
    • Proficient in the use of computers
    • Language skills preferred, but not essential
    • The successful candidate will be a hard working, self-motivated, strong communicator with good problem solving skills, initiative and attention to detail

    All applicants must apply using the RELEVANT LINK.