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:
