Regulatory Affair Officer

Roles and Responsibilities

1. To prepare and manage technical files/dossiers for products with regulatory agencies (FDA510K, CDSCO).
2. Take on the role of Management representative for the organization and manage ISO. 13485:2016 QMS by coordinating with internal and external cross-functional teams.
3. Coordinate and manage QMS and product audits (internal and external).
4. Managing post-market surveillance of products and coordinating reports to regulatory authorities as required.

Detailed Job Description

• Create and review documents used in design and development, monitor audits of various departments and quality control areas.
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
• Manage document control and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
• Manage non-conformance, corrective action preventive actions, and deviation.
• Develop and support the implementation of departmental and divisional policies and procedures.
• Review device labeling and advertising materials for compliance with global regulations; analyze and recommend appropriate changes.
• Review and sign off on product changes for compliance with applicable regulations.
• Participate with peers in the formulation of overall direction, processes, systems, and talent development for quality organizations.
• Manage and renew all the regulatory registrations.

Qualifications

• Mandatory: Experience with technical file preparation and filing with FDA510K or CE (IVDR/IVDD experience preferred).
• Mandatory: Experience in implementation and management of QMS (ISO 13485:2016). Candidates with ISO 13485 lead auditor certification will be preferred.
• 2 to 5 years of experience is preferred
• Knowledge of FDA medical device and drug regulations, guidance, and import/export requirements.