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  • Regulatory Affairs Consultant
    Regulatory Affairs Consultant
    10 days ago
    Full-time
    Hartsdale

    JOB SUMMARY: We are seeking an experienced Regulatory Affairs Consultant to provide expert guidance on compliance, documentation, and regulatory strategy. The consultant will support product registrations, regulatory submissions, audits, and ensure adherence to all applicable local, federal, and industry regulations. KEY RESPONSIBILITIES: Develop and implement regulatory strategies to support product approvals and compliance. Prepare, review, and submit regulatory documents, reports, and technical files. Ensure products meet regulatory requirements across relevant markets. Advise on regulatory changes, updates, and potential business impacts. Coordinate with internal teams to ensure documentation accuracy and readiness for audits. Communicate with regulatory agencies as needed for approvals or clarifications. Conduct compliance assessments and recommend corrective actions. Maintain detailed records of submissions, approvals, and regulatory correspondence. QUALIFICATIONS: Bachelor’s degree in Regulatory Affairs, Life Sciences, Pharmacy, Biotechnology, or related field. Proven experience in regulatory affairs within relevant industry (e.g., pharmaceuticals, medical devices, cosmetics, food, etc.). Strong knowledge of regulatory standards and submission processes. Excellent analytical, documentation, and communication skills. Ability to manage multiple projects and deliver within deadlines. PREFERRED SKILLS: Experience with FDA, EMA, or local regulatory authorities. Familiarity with quality management systems (ISO standards). Strong attention to detail and problem-solving skills. WORK SETUP: Contract / Consultant Remote or On-site depending on project needs

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  • Spanish Interpreter
    Spanish Interpreter
    1 month ago
    $20–$30 hourly
    Full-time
    Greenpoint, Brooklyn

    The Language Video-Telephone- Interpreter is responsible for handling calls on demand and renders the meaning of conversations between Spanish and English speakers. The interpreter breaks the communication barrier in various industries: Healthcare, Insurance, Financial, General Business, and 911. The interpreter processes information quickly and concisely and recognizes sensitive cultural differences. The interpreter is professional and courteous and uses appropriate, terminology and understands standard industry procedures and practices. The video and audio interpreting sessions may involve simple or complex, technical, or non-technical subjects. However, this position does not involve written translation; translators and other skilled linguists are encouraged to apply. The interpreters translate verbally. This is a remote position. The Interpreter works from his/her home office. It is essential to ensure a quiet & secure environment. Duties and Responsibilities Respond to video and audio interpreting sessions promptly and conduct interpretation in a friendly and professional manner. Participate in online, video and audio training sessions. Deliver interpretation services via video and expediently type data on a company-provided device, such as a laptop, to perform the job’s essential functions. Render correct concepts and meanings according to the conventions of established interpretation protocol, avoiding omissions or additions. Speak clearly in both languages using proper pronunciation, enunciation, and polite expressions. Maintain a professional demeanor throughout the video and audio interpreting sessions. Remain calm during video and audio interpreting sessions if one of the speakers is incoherent or upset, especially in emergencies such as 911 calls. Maintain punctuality and availability during scheduled work hours. Follow client instructions in compliance with protocol to ensure client expectations are met with the Limited English-speaking Person (LEP), avoiding interaction with the LEP without the client’s permission. Understand protocol and terminology for various industries including, but not limited to, Medical, Insurance, Finance and Law. Demonstrate commitment to cultural sensitivity and working in a diverse environment. Qualifications Fluency in Spanish and English and skilled in the associated cultural dynamics. High school diploma or equivalent. Ability to provide cultural competency and assess regional and accent differences to find ways of communicating with the LEP. Excellent listening, retention, and note-taking skills to maintain a high level of accuracy during interpretation. Education or work experience in language-related fields such as teaching, language assessment, translation or interpretation preferred. Must be able to adapt to any Kelly technology enhancements that improve service delivery and meet client demands. Must be at least 18 years of age. Legally authorized to work in the US. Ability to read and write the requested languages – highly preferred.

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