Regulatory Affairs Specialist

Job Location s: US-Remote | US-OH-Cincinnati

Company:
Meridian Bioscience, Inc.

Department:
Quality & Regulatory Affairs

# of Openings: 1

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision.

Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

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. This position supports compliance with applicable design control, software lifecycle, risk management, and quality system requirements through the review and assessment of technical documentation, verification and validation activities, and design changes. Works cross-functionally with Software Engineering, R&D, Regulatory Affairs, and Quality Assurance to identify compliance gaps, support remediation activities, and ensure appropriate documentation and objective evidence are maintained within the Design History File (DHF).

• Ensures that national and international compliance regulations for the design and development of medical devices are met and maintained throughout the lifecycle, including FDA's QSR (21 CFR Part 820), ISO 13485, MDSAP, IVDR, and others.
• Assists with the preparation, submission, and management of regulatory dossiers, Technical Files, and FDA marketing submissions (510(k) Pre-Marketing Notifications, Pre-Submissions) in accordance with required regulations/standards.
• Support implementation and maintenance of design controls in accordance with applicable regulatory requirements and internal quality system procedures.
• Review and assess design and development documentation, including User Needs, Product Requirements, Software Requirements Specifications, Design Plans, and Design History Files.
• Maintain regulatory files, information, logs, and databases to ensure data continuity by collecting information and entering it accurately into various applications.
• Participates in the development and execution of global regulatory strategy in collaboration with interdisciplinary project teams to support compliance with international regulatory and quality system requirements and overall business objectives.
• Support development and maintenance of Design Traceability Matrices (DTMs), ensuring traceability between design inputs, design outputs, risk controls, and verification and validation activities.
• Support software lifecycle compliance activities, including review of software documentation, change control, and verification records in accordance with IEC 62304.
• Assist with software cybersecurity documentation and compliance activities, including vulnerability management, risk assessments, and supporting records.
• Assists with the review and approval of product technical documentation (i.e. requirements documents, verifications/validations, Safety Data Sheets, manufacturing procedures, and labeling).
• Completes evaluation of the regulatory impact of changes associated with product design change.
• Author and/or revise regulatory SOPs to align with current regulations and best regulatory practices.
• Ensures that required documentation is properly assembled and maintained per quality system processes and procedures.
• Participate on long-term projects supporting the business and quality objectives of the organization.
• Other duties as assigned.

• Bachelor of Science degree in Biology, Biochemistry, Microbiology or related field with 2 years of experience in Regulatory Affairs;
  Quality Assurance, Quality Systems, Design Control, Regulatory Affairs or equivalent.
• One year 1 year of direct ISO 14971 Risk Management experience is required, including preparation of Risk Management Plans, Hazard Assessments, Usability Engineering, Human Factors Analysis, etc.
• Experience with design control, product development, validation and verification activities preferred.
• Experience with IVDR is preferred.
• Experience supporting regulatory submissions…