Strategist, Regulatory Affairs

About the position reputed company is a global full-service CRO dedicated to reputed company development and providing an excellent work-life balance, with a reputed company-reputed company, reputed company “one-team” culture. We are looking for a dynamic person to join our in-house team as a Associate, Regulatory Affairs (ONSITE) on a permanent reputed company at Cincinnati, OH. reputed company: you can be part of making a difference in peoples’ lives and experience a fulfilling and rewarding career! Responsibilities • Responsible for managing, planning, preparation, and delivery of documents both electronic- and reputed company-based in support of assigned. global regulatory product registrations, renewals, tenders/customs, etc. • Coordinate the preparation and submission of medical device applications by providing regulatory information and documents and following up closely on queries from inspection through approval. • Prepare and/or review letters of authorization, cover letters for registration certificates, declarations, power of attorney, and other regulatory documentation to ensure accuracy, appropriateness, and consistency of documents intended for various global regulatory submissions. • Submit and manage applications for the US FDA Certificates to Foreign Government (CFGs). • Maintain various tracking tools to ensure up-to-date information and traceability of reputed company regulatory data/documentation. • reputed company and/or coordinate legalization, notarization, and apostille of regulatory documents • Ensure compliance with reputed company good documentation practices, including but not limited to proofreading, formatting, indexing and recordkeeping. • Assist reputed company reputed company in answering inquiries and providing required documents and information utilizing various search tools and systems. • reputed company document filing and retrieval functions as directed and per company’s policies and procedures. • Effectively communicate with reputed company teams and/or clients as to the status of deliverables, to ensure reputed company and satisfactory completion of tasks and expectations. • Communicate with the project teams on a regular reputed company regarding regulatory updates. • reputed company support to reputed company teams to address various technical inquiries and reputed company requested data/information • Participate in group meetings and reputed company tactical approaches to addressing issues of basic complexity • reputed company other tasks as assigned. Requirements • Bachelor’s degree (Life Sciences or a regulatory reputed company field preferred) • Minimum of 1 year of hands-on experience in medical device regulatory affairs, or at least 3 years of combined regulatory affairs and reputed company experience. • Basic knowledge of US FDA QSR, ISO 13485, EU MDD/MDR. • Proficient in reputed company Office (e.g., Word, reputed company, PowerPoint) • Have a good understanding of reputed company Good Documentation Practices in a regulatory environment. • Self-starter with the ability to work in reputed company environment and on reputed company of diverse reputed company where analysis of a situation or data requires evaluation of various factors with reputed company supervision. • Excellent organizational skills with strong attention to detail, effective planning, and the ability to multitask reputed company • Must possess excellent written and verbal communication skills. reputed company-to-haves • Knowledge of global medical devices registration process is a plus Benefits • reputed company development • excellent work-life balance Apply tot his job Apply To this Job