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Regulatory Affairs Specialist
Location
Worldwide
Posted
52 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Regulatory Affairs Specialist
Teladoc Health
Role Description Under the general direction of the Regulatory Affairs Director, the Regulatory Affairs Specialist will be responsible for participating in regulatory activities, preparing regulatory filings, and supporting registrations and strategies for domestic and key international regions (OUS). - Provides high-quality support and assistance in areas related to regulatory strategy, product classification, and submissions to introduce new or changed medical devices and radio equipment to markets worldwide for Teladoc Health, Inc. - Assists with identifying applicable regulations, guidance documents, and standards for medical devices and radio equipment. - Prepares, reviews and files, as appropriate, FDA Annual Reports on Radiation Safety, EU technical documentation, Canada Medical Device Establishment Licenses, and no-file justifications. - Ensures consistency, completeness, and accuracy in regulatory documentation and adherence to regulations, applicable guidelines, and the Quality Management System. - Drives development and updates to regulatory affairs procedures, work instructions, and templates to improve operations or reflect changing regulatory requirements in collaboration with stakeholders and in line with the Quality Management System. - Conducts reviews of promotional and advertising material for compliance with standards and regulatory requirements. Assists with labeling development and reviews. - Conducts regulatory research and data collection to inform regulatory strategy and submissions. Understands, investigates, and evaluates regulatory history of products for context. - Supports FDA, notified body and other regulatory body inspections and audits, as needed. - Works in close collaboration with stakeholders and internal partners to achieve business objectives. - Maintains ongoing surveillance on the changing regulatory landscape, including domestic and international radio equipment and medical device regulations and guidance documents. - Reviews Engineering Change Requests to ensure compliance with regulatory standards and Quality Management System requirements. Qualifications - BS/BA or equivalent with 3-6 years of experience of working in an FDA or ISO regulated environment. - Familiar with industry standards and regulations (e.g. 21 CFR 820, ISO 13485, and ISO 14971). - Be able to identify missing information and evaluate accuracy of the presented information. - Demonstrates strong attention to detail; monitors own work to ensure quality. - Listens and gets clarification; responds well to questions; understands nuances related to documentation, and customer matters. - Writes clearly and informatively; varies writing style to meet needs; able to read and interpret written information. - Follows policies and procedures; supports organization's goals and values. - Proficient in Microsoft Office (Outlook, Word, Excel, and Power Point), Adobe Acrobat, and Social Media web platforms. Benefits - Enjoy an inclusive benefits program centered around you and your family, with tailored programs that address your unique needs.
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