Job Description

Regulatory Affairs International Operations Consultant

Job Summary:

We are seeking a highly skilled and motivated Medical Device Regulatory Affairs Consultant with extensive experience in regulatory operations to join our Aortic Heart Valve team . The successful candidate will play a critical role in ensuring regulatory compliance and facilitating smooth regulatory affairs activities across global markets. This role will focus on regulatory change assessments , compiling and managing documents for US and international submissions ( LATAM, APAC, and the Middle East ), facilitating document transfers to other countries , supporting change orders , obtaining necessary certificates such as CFGs (Certificates of Free Sale) , assisting with Regulatory Affairs Committees (RACs) , addressing international regulatory business requests, and hands-on international registrations .

Key Responsibilities:

• Document Management: Locate, compile, and organize documents required for US and international regulatory submissions , ensuring completeness and accuracy.
• Regulatory Compliance & Change Assessments: Support regulatory change assessments , change orders, and documentation updates to ensure compliance with global regulatory standards.
• International Regulatory Support & Submissions:
• Facilitate document preparation and submission processes for APAC, the Middle East, LATAM, and the EU .
• Hands-on involvement in international registrations for various regulatory bodies.
• Address international business requests, prepare documentation, and liaise with regulatory authorities in LATAM, the Middle East, and APAC .
• Certificate Acquisition: Obtain necessary documents such as CFGs (Certificates of Free Sale) to support regulatory submissions and international business requirements.
• Support RACs: Assist in coordinating and supporting Regulatory Affairs Committees (RACs) , providing necessary documentation and guidance as required.
• Project Support: Contribute to general project work within the regulatory affairs space, collaborating with cross-functional teams to achieve project objectives and milestones.
• Regulatory Intelligence: Stay updated on changes in global regulatory requirements , standards, and guidelines applicable to medical devices , incorporating findings into regulatory operations and strategies.
• Process Improvement: Identify opportunities for process improvements within regulatory affairs operations, implementing changes to enhance efficiency and effectiveness.
• Qualifications:

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