Remote Regulatory Affairs Specialist - Medical Devices & IVDR

Meridian Bioscience, Inc.; Cincinnati (OH); Remote; USD 85,000 - 110,000; Full time

Job summary

Meridian Bioscience, Inc. is seeking a Regulatory Affairs Specialist to support regulatory and quality activities for in vitro diagnostic instruments and related software across development lifecycle.

You will work with Software Engineering, R&D, Regulatory Affairs, and QA to identify compliance gaps, document evidence, and drive remediation in the DHF. The role requires a BS degree and 2+ years in Regulatory Affairs or Quality Systems, with experience in design controls, risk management and

Qualifications

• Bachelor degree in Biology, Biochemistry, Microbiology or related field with 2 years of Regulatory Affairs or quality systems experience.
• Experience with ISO 14971 Risk Management including risk plans, hazard assessments, usability and human factors analyses.

Responsibilities

• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, IVDR throughout product lifecycle.
• Assist with regulatory dossiers, Technical Files, and FDA submissions (510(k), PMA) per regulations.
• Support design controls implementation and maintenance per applicable regulatory requirements.
• Review design and development documentation, including User Needs, Product Requirements, Software Requirements Specifications, and Design History Files.
• Maintain regulatory files and databases to ensure data continuity across applications.
• Collaborate on global regulatory strategy with cross-functional teams to meet regulatory and quality objectives.
• Support development and maintenance of Design Traceability Matrices (DTMs) and software lifecycle compliance (IEC 62304).
• Assist with cybersecurity documentation and risk assessments for software.
• Review and approve product technical documentation (requirements, verifications/validation, SDS, procedures, labeling).
• Evaluate regulatory impact of product design changes and update SOPs accordingly.
• Ensure documentation is properly assembled per quality system processes and procedures.

Skills

Regulatory affairs

ISO 14971

Design controls

Regulatory submissions

Attention to detail

Communication skills

Education

Bachelor of Science in Biology/Biochemistry/Microbiology or related field

Tools

MS Office

Job description

Meridian Bioscience, Inc. is seeking a Regulatory Affairs Specialist to support regulatory and quality activities for in vitro diagnostic instruments and related software across development lifecycle.

You will work with Software Engineering, R&D, Regulatory Affairs, and QA to identify compliance gaps, document evidence, and drive remediation in the DHF. The role requires a BS degree and 2+ years in Regulatory Affairs or Quality Systems, with experience in design controls, risk management and