Regulatory Affairs Specialist – IVD & Quality Compliance

Meridian Bioscience International Limited; United States; Remote; USD 90,000 - 130,000; Full time

Job summary

Meridian Bioscience is seeking a Regulatory Affairs/Quality professional to support compliance activities for in vitro diagnostic instruments and software across the product lifecycle. You will collaborate with Software Engineering, R&D, Regulatory Affairs, and Quality Assurance to identify gaps, support remediation, and maintain DHF documentation.

Responsibilities include preparing regulatory submissions, maintaining design controls, and supporting software lifecycle and cybersecurity

Qualifications

• Bachelor of Science in Biology, Biochemistry, Microbiology or related field with 2 years of Regulatory Affairs/Quality Systems experience.
• Experience with design control, product development, validation and verification.
• Experience with IVDR and regulatory submissions (510(k), PMA) preferred.
• Knowledge of 21 CFR 820, ISO13485 and related regulatory requirements.
• Familiarity with risk management (IEC 14971) and SOR/98-282 is a plus.

Responsibilities

• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, MDSAP, IVDR throughout product lifecycle.
• Prepare, submit, and manage regulatory dossiers and FDA filings (510(k), PMAs).
• Maintain design controls and quality system procedures per regulations.
• Review design and development documentation (User Needs, Product Requirements, SRS, DHF).
• Maintain regulatory files and data continuity across applications.
• Participate in the development of global regulatory strategy with cross-functional teams.
• Support Design Traceability Matrices (DTMs) ensuring traceability from design inputs to verifications.
• Support software lifecycle compliance per IEC 62304.
• Assist with software cybersecurity documentation, risk assessments, and supporting records.
• Review product documentation (requirements, verifications/validations, SDS, procedures, labeling).
• Evaluate regulatory impact of design changes.

Skills

Regulatory Affairs

Quality Systems

Documentation

Software compliance

Education

B.S. in Biology/Microbiology

Tools

MS Office

Job description

Meridian Bioscience is seeking a Regulatory Affairs/Quality professional to support compliance activities for in vitro diagnostic instruments and software across the product lifecycle. You will collaborate with Software Engineering, R&D, Regulatory Affairs, and Quality Assurance to identify gaps, support remediation, and maintain DHF documentation.

Responsibilities include preparing regulatory submissions, maintaining design controls, and supporting software lifecycle and cybersecurity