Regulatory Affairs Specialist

Company : Karwell Technologies

Responsibilities:

• The role includes obtaining and maintaining regulatory approvals, supporting quality management system (QMS) objectives, and ensuring adherence to applicable regulatory standards.
• The Regulatory Affairs position is responsible for global product registrations and ensuring regulatory compliance in the design, manufacturing, and sales of medical devices (including Class I and II devices, software as a medical device, and de novo devices).
• 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 labeling.
• 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.
• 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.
• Complete QMS training activities and provide regulatory expertise to continuous improvement activities.
• Comply with all company policies and procedures.

Requirements:

• Bachelor of Science degree.
• 5-7 years of regulatory affairs experience in medical device industry, preferably with respiratory devices.
• Strong understanding 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.

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