Regulatory Affairs Specialist

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🔥 0 minutes ago

🏈 Ohio – Remote

🏈 Ohio – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

👻 Ghost score 10%

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Meridian Bioscience Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Grant on 2022-01

Healthcare • Consulting • Food & Beverage

Meridian Bioscience Inc. is a leading manufacturer of molecular and immunological reagents designed for diagnostic applications. The company specializes in providing innovative solutions to enhance point-of-care diagnostics and streamline assay development for various medical conditions, including infectious diseases and cancers. Meridian is dedicated to advancing medical diagnostics and improving patient outcomes through its high-quality products and services.

📋 Description

• Support Regulatory Affairs, Design Quality Assurance, and software compliance activities for IVD instruments and associated software throughout the product development lifecycle • Ensure compliance with medical-device regulations and standards including FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, and IVDR • Assist with preparation, submission, and management of regulatory dossiers, Technical Files, and FDA marketing submissions including 510(k) Pre-Marketing Notifications and Pre-Submissions • Support implementation and maintenance of design controls and review design and development documentation • Maintain regulatory files, logs, databases, and accurate records • Participate in global regulatory strategy with interdisciplinary project teams • Support Design Traceability Matrices and traceability between design inputs, outputs, risk controls, and verification and validation activities • Support software lifecycle compliance, change control, verification records, and cybersecurity documentation • Review and approve product technical documentation, including requirements, verification/validation, safety data sheets, manufacturing procedures, and labeling • Evaluate regulatory impact of product design changes • Author and revise regulatory SOPs • Assemble and maintain required documentation according to quality system procedures • Participate in long-term projects supporting business and quality objectives

🎯 Requirements

• Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field with 2 years of experience in Regulatory Affairs, Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent • One year of direct ISO 14971 Risk Management experience is required, including preparation of Risk Management Plans, Hazard Assessments, Usability Engineering, Human Factors Analysis, etc. • Experience with design control, product development, validation and verification activities preferred • Experience with IVDR preferred • Experience supporting regulatory submissions (e.g., 510(k)s and/or PMAs, and/or international registrations) strongly preferred • Ability to maintain accurate and concise records and uphold regulatory and quality system requirements including 21 CFR 820, ISO 13485, 2017/746, and SOR/98-282 • Knowledge of International Registrations, Health Canada, IVDR, ISO 13485:2016 • Awareness of IEC 60601, IEC 61010, and IEC 62366 technical standards • Ability to work independently and resolve quality issues collaboratively • Strong organization, attention to detail, prioritization, time management, and ability to meet deadlines under pressure • Exceptional written and verbal communication, interpersonal, problem-solving, and interaction skills • Strong proficiency with MS Office applications (Word, Excel, PowerPoint, Outlook) • Must be willing to travel as needed

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