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  • Regulatory Affairs Consultant
    Regulatory Affairs Consultant
    8 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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  • Medical Coder
    Medical Coder
    19 days ago
    Full-time
    New York

    Job description & requirements Medical Coders (Mid-Level) AIMRRA is seeking multiple Mid-Level Medical Coders for one of our staffing agencies. The Coders are primarily responsible for reviewing health information. The coder reviews medical records for specific criteria and validates the submission of code year sets from selected organizations to the government and commercial clients. The position requires review of protected health information and must maintain strict confidentiality when addressing or referring to such records. The coders must have the ability to use a variety of office equipment and computer software, and to work independently. The candidate(s) will be hired as an employee up to 40 hours per week (flexible scheduling). The job title and salary for this position will be determined based on the candidate’s relevant experience and the results of a standardized coding assessment. Candidates must achieve a passing score on the assessment before their application can be further considered. Responsibilities: Most of the coding will be done by the Mid-Level Coders. The Mid-Level Coders will be involved from intake through abstraction. Mid-Level Coders with education of proper coding that is aligned to general industry practices. Analyze protected health information according to project-specific rules. Participate in the Intake Process of records. Assign ICD-10-CM codes according to the guidelines as defined by the AMA. Discuss project-related discrepancies with Team Lead(s). Maintain coding credentials and continuing education hours. Possess and maintain a current and comprehensive understanding of coding rules, changes, and guidelines as defined by the AMA. Qualified Candidate: Must possess a minimum experience or knowledge in abstracting and ICD-10 coding of general acute hospital (inpatient and outpatient). Knowledge in anatomy and physiology, pathology of disease, and medical terminology required. Ability to write appropriate correspondence and effectively communicate with other members of our team’s personnel, clients, and customers as necessary. Must be able to work independently with little or no supervision. Licenses/Certification: All coders must have experience in abstracting ICD-10 (blended HCC model) coding and have one or more of the following certifications: Certified Risk Adjustment Coder (CRC) Certified Professional Coder (CPC) Required Travel No required travel Applicant Location US residents only

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