Regulatory Affairs Specialist III

Responsibilities

• Develop regulatory strategies to achieve market clearance in an effective and efficient manner
• Prepare, submit, and maintain product registrations, certifications, and approvals to meet US, EU and other regulatory requirements as applicable
• 510(k) and/or De Novo submissions for FDA
• Technical documentation for EU MDR compliance
• International product registration activities to meet business objectives
• Provide regulatory input to support product labelling
• Monitor new and changing regulatory requirements and ensure the business understands relevant impacts
• Lead corrective and preventive action (CAPA) efforts as assigned
• Provide regulatory input throughout the product lifecycle, including design controls, to support regulatory submissions
• Change Control Management: Assess and document regulatory impacts of design changes, manufacturing changes, et al, including related updates to product registrations
• Support and participate in internal and external audits and regulatory agency inspections

Requirements

• Bachelor of Science degree
• 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices
• In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR
• In-depth knowledge of ISO 14971 risk management for medical devices
• Proficiency in database systems and advanced Microsoft Excel skills for reporting and analysis
• Understanding of continuous improvement principles
• Strong verbal and written communication skills, with the ability to articulate complex technical issues clearly and effectively to cross-functional teams and regulatory bodies
• Strong analytical and critical thinking skills, with the ability to resolve complex complaints and implement long-term solutions
• High level of attention to detail and accuracy, particularly when preparing regulatory submissions