Regulatory Affairs Specialist

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.
• (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.
• 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 :