Senior SW Compliance Specialist – Regulatory Affairs, Design Assurance

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Meridian Bioscience Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Grant on 2022-01

Biotechnology • Healthcare Insurance • Pharmaceuticals

Meridian Bioscience Inc. is a leading manufacturer of molecular and immunological reagents designed for diagnostic applications. The company specializes in providing innovative solutions to enhance point-of-care diagnostics and streamline assay development for various medical conditions, including infectious diseases and cancers. Meridian is dedicated to advancing medical diagnostics and improving patient outcomes through its high-quality products and services.

📋 Description

• Responsible for supporting Meridian’s regulatory and quality processes • Assist the regulatory department with product compliance throughout all stages of the product lifecycle • Provide support and guidance to quality and regulatory activities, including Design Control activities • Supports and helps draft sections of regulatory submissions for domestic, worldwide commercialization • Drafts, evaluates, and reviews technical protocols and data in support of clinical trials • Reviews software architecture, software requirements, traceability, verification and validation documentation • Provides direct support associated with adverse events, medical device reportable events and product recall activities • Supports cybersecurity compliance activities

🎯 Requirements

• Bachelor of Science degree in Biology, Biochemistry, Microbiology, Software Engineering, Computer Science, Computer Engineering, Biomedical Engineering, Electrical Engineering, or other related scientific, engineering, or technical discipline required • A minimum of 4–6 years of direct Regulatory Affairs, Design Assurance, Software Quality, or related regulated industry experience is required • Proven knowledge of FDA and ISO regulated environment • Experience with design, development, and clearance of medical devices • Knowledge of FDA software documentation requirements • Experience reviewing software lifecycle documentation • Working knowledge of cybersecurity requirements applicable to medical devices • Ability to assess software, firmware, cybersecurity, and connectivity changes for regulatory impact

🏖️ Benefits

• Health insurance • Flexible work arrangements • Professional development opportunities