What are the responsibilities and job description for the Regulatory Affairs Consultant position at ALKU?
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 :
