Regulatory Affairs Specialist III

Responsibilities

• Obtain and maintain regulatory approvals for global product registrations.
• Safeguard regulatory compliance in the design, manufacturing, and sales of medical devices (Class I, II, software as a medical device, and de novo devices).
• Develop and implement regulatory strategies to achieve market clearance efficiently.
• Prepare, submit, and maintain product registrations, certifications, and approvals to comply with US, EU, and other regulatory requirements.
• Support quality management system (QMS) objectives and ensure adherence to applicable regulatory standards.
• Provide regulatory input to support product labeling and monitor new regulatory requirements.
• Lead corrective and preventive action (CAPA) efforts as assigned.
• Support product development throughout the lifecycle, including design controls, for regulatory submissions.
• Audit and inspect support, participating in internal and external audits and regulatory agency inspections.
• Assist with QMS training activities and provide regulatory expertise for continuous improvement initiatives.
• Participate in Lean and Kaizen initiatives.
• Comply with all company policies and procedures.

Requirements

• Bachelor of Science degree in a relevant field.
• At least 57 years of regulatory affairs experience in the medical device industry, preferably with respiratory devices.
• Current experience leading multiple successful 510(k) clearances and CE marking.
• In-depth knowledge of medical device product life cycle and regulatory requirements.
• In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part 820), and EU MDR.
• 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.