Regulatory Affairs Specialist

Meridian Bioscience, Inc. • Cincinnati, OH

1d

About The Position

The Regulatory Affairs Specialist supports Regulatory Affairs, Design Quality Assurance, and software compliance activities for Meridian’s in vitro diagnostic (IVD) instruments and associated software throughout the product development lifecycle. The role supports compliance with design control, software lifecycle, risk management, and quality system requirements by reviewing and assessing technical documentation, verification and validation activities, and design changes. The specialist works cross-functionally with Software Engineering, R&D, Regulatory Affairs, and Quality Assurance to identify compliance gaps, support remediation, and maintain appropriate documentation and objective evidence in the Design History File (DHF).

The position supports compliance with national and international medical-device design and development requirements, regulatory submissions and dossiers, design controls, software lifecycle and cybersecurity documentation, product technical documentation, and regulatory impact assessments for design changes. It also contributes to global regulatory strategy, maintains regulatory records and databases, authors or revises regulatory SOPs, and participates in projects supporting business and quality objectives.

Requirements

• Bachelor of Science degree in Biology, Biochemistry, Microbiology, or a related field.
• At least 2 years of experience in Regulatory Affairs, Quality Assurance, Quality Systems, Design Control, Regulatory Affairs, or equivalent.
• At least 1 year of direct ISO 14971 Risk Management experience, including preparation of Risk Management Plans, Hazard Assessments, Usability Engineering, and Human Factors Analysis.
• Knowledge of international registrations, Health Canada, IVDR, and ISO 13485:2016.
• Awareness of technical standards including IEC 60601, IEC 61010, and IEC 62366 for establishing the safety and effectiveness of medical electrical equipment.
• Ability to work independently and proactively identify or resolve quality issues and discrepancies in a diplomatic, flexible, and constructive manner.
• Strong organization and attention to detail, with the ability to prioritize workloads, meet critical deadlines, and perform under pressure in a fast-paced environment.
• Ability to adapt to changing priorities, manage time, and complete tasks and multiple projects on time.
• Exceptional written and verbal communication, interpersonal, and problem-solving skills, and ability to interact effectively with people at all organizational levels, internally and externally.
• Strong working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Willingness to travel as needed.
• 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.

Nice To Haves

• Experience with design control, product development, and validation and verification activities.
• Experience with IVDR.
• Experience supporting regulatory submissions, such as 510(k)s, PMAs, or international registrations.

Responsibilities

• Ensure compliance with applicable national and international medical-device design and development regulations throughout the product lifecycle, 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 under applicable regulatory requirements and internal quality system procedures.
• Review and assess design and development documentation, including User Needs, Product Requirements, Software Requirements Specifications, Design Plans, and Design History Files.
• Maintain regulatory files, information, logs, and databases, accurately collecting and entering information into applications.
• Participate in developing and executing global regulatory strategy with interdisciplinary project teams.
• Support development and maintenance of Design Traceability Matrices, ensuring traceability among design inputs, design outputs, risk controls, and verification and validation activities.
• Support software lifecycle compliance, including review of software documentation, change control, and verification records in accordance with IEC 62304.
• Assist with software cybersecurity documentation and compliance, including vulnerability management, risk assessments, and supporting records.
• Assist with reviewing and approving product technical documentation, including requirements documents, verification and validation records, Safety Data Sheets, manufacturing procedures, and labeling.
• Evaluate the regulatory impact of product design changes.
• Author and revise regulatory SOPs to align with current regulations and best regulatory practices.
• Ensure required documentation is assembled and maintained according to quality system processes and procedures.
• Participate in long-term projects supporting organizational business and quality objectives.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level