Regulatory Compliance Specialist

2 weeks ago


madurai, India beBeeCompliance Full time

Job Title: Regulatory Compliance SpecialistAbout the RoleThis key position is responsible for ensuring medical devices meet regulatory standards set by prominent bodies, such as the FDA, EU MDR, and international authorities.Regulatory Document Management: Prepare, review, and submit necessary documents and technical files/dossiers for CE marking and international registrations.Regulatory Assessments: Support assessments for product changes, labeling updates, and post-market activities to ensure compliance.Databases and Tracking: Maintain and update regulatory databases, tracking submissions, approvals, and renewals on OBL products.Regulatory Updates: Monitor and interpret evolving regulations, communicating their impacts to relevant stakeholders.Familiarity with U.S. FDA regulations, EU Medical Device Regulation, and international standards is essential. A bachelor's degree in pharmacy and 1–3 years of experience in regulatory affairs are required.Key Skills and QualificationsBachelor's Degree in Pharmacy: Essential for this role.Experience in Regulatory Affairs: 1-3 years of experience in this field.FDA Regulations, EU MDR, International Standards: Proficiency in these regulations and standards is crucial.In this dynamic role, you will be working closely with various teams to ensure that our medical devices meet the highest regulatory standards. If you have a strong background in regulatory affairs and are passionate about ensuring compliance, we encourage you to apply.



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