[Hiring] Regulatory Affairs Specialist @Meridian Bioscience, Inc.

Role Description

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).

Key Duties

• 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.

Qualifications

• 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 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 (e.g., 510(k)s and/or PMAs, and/or international registrations) is strongly preferred.
• Highly motivated, detail oriented, must have a constant awareness of customer requirements and must demonstrate an ability to make fact-driven decisions; maintain accurate and concise records, uphold regulatory and quality system requirements including 21 CFR 820, ISO13485, 2017/746, and SOR/98-282.
• Knowledge with International Registrations, Health Canada, IVDR, ISO13485:2016.
• Awareness of technical standards, including IEC 60601, IEC 61010, IEC 62366 for establishing the safety and effectiveness of medical electrical equipment.
• Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
• Must be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast-paced environment.
• Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.
• Must possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving and ability to interact effectively with all levels of the organization both internally and externally.
• Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook).
• Must be willing to travel as needed.