Job 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