Regulatory Affairs Lead: IVD & Software Compliance

Meridian Bioscience, Inc.; Oregon; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Meridian Bioscience, Inc. is seeking a Regulatory Affairs professional to support compliance activities for in vitro diagnostic instruments and software across the product lifecycle.

The role collaborates with Software Engineering, R&D, Regulatory Affairs, and QA to identify compliance gaps and ensure documentation integrity in the Design History File. You will participate in global regulatory strategies, manage design controls, and support software lifecycle compliance per IEC 62304, with a

Qualifications

• BS in Biology, Biochemistry, Microbiology or related field with 2 years' regulatory affairs/QA experience.
• Minimum 1 year ISO 14971 Risk Management experience required.
• Experience with design control, product development, validation and verification is preferred.
• Experience with IVDR and regulatory submissions (510(k)/PMA) is preferred.
• Strong attention to detail, ability to work under pressure and meet deadlines; travel as needed.

Responsibilities

• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, IVDR throughout the product lifecycle.
• Assist with regulatory dossiers, Technical Files, and FDA submissions (510(k) pre-market) as required.
• Support implementation and maintenance of design controls per regulatory requirements and quality procedures.
• Review design and development documentation (User Needs, Product Requirements, SRS, DHF).
• Maintain regulatory files and logs across multiple applications to ensure data continuity.
• Collaborate on global regulatory strategy with interdisciplinary teams to meet business objectives.
• Support Design Traceability Matrix development linking inputs, outputs, and risk controls.
• Review software lifecycle compliance, including IEC 62304 related records.
• Assist with software cybersecurity documentation and risk assessments.
• Review and approve product technical documentation (requirements, verifications, safety data sheets).
• Evaluate regulatory impact of design changes and update documentation accordingly.
• Draft/regulatory SOPs to align with current regulations and best practices.
• Ensure proper documentation per quality system processes.
• Participate in long-term projects supporting business goals.

Skills

Regulatory affairs

Quality systems

Design control

Documentation management

Cross-functional collaboration

Regulatory submissions

IEC 60601/62304 knowledge

Education

Bachelor of Science in Biology/ Biochemistry/ Microbiology

Tools

MS Office

Job description

Meridian Bioscience, Inc. is seeking a Regulatory Affairs professional to support compliance activities for in vitro diagnostic instruments and software across the product lifecycle.

The role collaborates with Software Engineering, R&D, Regulatory Affairs, and QA to identify compliance gaps and ensure documentation integrity in the Design History File. You will participate in global regulatory strategies, manage design controls, and support software lifecycle compliance per IEC 62304, with a