Regulatory Affairs Specialist

Meridian Bioscience Inc.

. Support Regulatory Affairs, Design Quality Assurance, and software compliance activities for IVD instruments and associated software throughout the product development lifecycle .

Posted 11/4/2026full-timeRemote • Ohio • United StatesJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and Quality Assurance for IVD instruments, ensuring compliance with FDA QSR, ISO 13485, and IVDR standards. Proficient in managing regulatory submissions, design controls, and maintaining accurate documentation throughout the product development lifecycle.

Highest-signal resume keywords

Regulatory Affairs ExperienceISO 14971 Risk ManagementRegulatory Submissions (510(k), PMA)Design Control and Quality SystemsIVDR Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory ComplianceDesign ControlRisk Management PlansVerification and ValidationTechnical Documentation ReviewRegulatory Dossier PreparationChange ControlCybersecurity DocumentationQuality System ProceduresInterdisciplinary Project Collaboration

Soft Skills

Attention to DetailTime ManagementProblem-SolvingInterpersonal SkillsCommunication Skills

Tools & Technologies

MS Office ApplicationsRegulatory DatabasesDesign Traceability Matrices

Industry Keywords

FDA QSR (21 CFR Part 820)ISO 13485MDSAPIVDRIEC 60601IEC 61010IEC 62366Health CanadaInternational RegistrationsQuality Assurance

Tech Stack

Tools & technologies

Cyber Security

About the role

Key responsibilities & impact

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

What you’ll need

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