Regulatory Affairs Specialist

About This Role

This specialist role focuses on ensuring that medical devices and equipment meet all necessary regulatory standards. It involves preparing and submitting documentation to authorities and maintaining accurate records of submissions and approvals.

Responsibilities

• Ensure regulatory compliance for medical devices and equipment by preparing and submitting required documents to relevant authorities
• Develop and maintain accurate records of regulatory submissions, including product approvals and recalls
• Collaborate with cross-functional teams to identify potential risks and develop strategies to mitigate them
• Provide guidance on regulatory requirements to internal stakeholders, ensuring adherence to company policies

Requirements

• 5-8 years of experience in Regulatory Affairs or related field (Medical Devices & Equipment)
• Strong understanding of regulatory compliance, regulations, and guidelines governing the industry
• Proficiency in preparing complex regulatory documentation (e.g., applications, reports) according to specific formats