Software Compliance jobs

Regulatory Affairs Specialist

Meridian Bioscience, Inc. · Posted Nov 4, 2026

Remote
Remote
2+ years

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Responsible for supporting 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.

Responsibilities

Ensures compliance with national and international regulations for medical device design and development
Assists with preparation, submission, and management of regulatory dossiers and FDA marketing submissions
Supports implementation and maintenance of design controls
Reviews and assesses design and development documentation
Maintains regulatory files and databases

Requirements

Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field
Nice to have: Experience with IVDR
Nice to have: Experience with regulatory submissions (510(k), PMA, international registrations)

Skills

Regulatory Affairs Quality Assurance Quality Systems Design Control Risk Management

Technical Product Analyst

Technical Product Analyst

Compensation

Responsibilities

Requirements

Skills

Benefits

Regulatory Affairs Specialist

Responsibilities

Requirements

Skills