Regulatory Affairs Specialist, IVD & Quality Compliance

Meridian Bioscience International Limited; Cincinnati (OH); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Meridian Bioscience is seeking a Regulatory Affairs professional to support design controls, software lifecycle compliance and quality system activities for its IVD instruments and related software. You will review technical documentation, verification, and validation records throughout the product development lifecycle and collaborate across software, R&D, regulatory and QA teams to close compliance gaps.

The role requires a BS in biology/biochemistry/microbiology with 2 years in regulatory

Qualifications

• Bachelor of Science in Biology, Biochemistry, Microbiology or related field with 2 years of experience in Regulatory Affairs
• Regulatory Affairs; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent
• Experience with regulatory submissions (e.g., 510(k)s and/or PMAs) is strongly preferred
• Knowledge with International Registrations, Health Canada, IVDR, ISO13485:2016
• Strong communication, organizational and problem-solving skills; ability to work cross-functionally

Responsabilités

• Ensure compliance with FDA QSR, ISO 13485, MDSAP, IVDR and other regulations throughout product lifecycle
• Assist with preparation, submission and management of regulatory dossiers and technical files
• Support implementation and maintenance of design controls and software lifecycle compliance
• Review design and development documentation, risk management and DHF records
• Maintain regulatory files and databases, ensuring data accuracy and traceability
• Collaborate with Software Engineering, R&D, Regulatory Affairs and QA on regulatory strategy
• Develop and maintain Design Traceability Matrices linking inputs, outputs and verifications
• Assist with regulatory impact assessment of product design changes

Description du poste

Meridian Bioscience is seeking a Regulatory Affairs professional to support design controls, software lifecycle compliance and quality system activities for its IVD instruments and related software. You will review technical documentation, verification, and validation records throughout the product development lifecycle and collaborate across software, R&D, regulatory and QA teams to close compliance gaps.

The role requires a BS in biology/biochemistry/microbiology with 2 years in regulatory