RAQA Manager

Job Details

＜Job Title＞

17756 RAQA Manager

＜Job Descriptions＞

・Compile regulatory submissions for Marketing Authorization for products
・Address inquiries from government agencies and notified bodies
・Compile regulatory submissions to support notifications and partial changes for the products
・Compile documentation to support Manufacturer Registration
・Compile and submit documentation relating to reimbursement of medical devices
・Compile, submit documentation and provide support to obtain and maintain distribution licenses in Japan
・Support RAQA effort to prepare, submit and manage facility inspections/audits to obtain marketing authorization, manufacturer registrations, QMS certificates, distribution licenses and other necessary approvals
・Provide regulatory and quality support to MAHs of the products, Distributors and 3PL as needed
・Contribute to the development and implementation of the regulatory strategies in compliance with Japanese regulations
・Perform or support operator audits as needed
・Contribute and lead the development of a local Quality Management System compliant with Japan regulation
・Manage and oversee the processes for customer complaints and feedback in Japan as needed
・Monitor, prepare, and support compliance to adverse events reports, recalls and other required post-market surveillance regulations
・Provide guidance, support, training and input on the interpretation and implementation of regulations, guidelines and SOPs
・Review, monitor and approve documentation to ensure compliance with standards, regulations and guidance documents
・Maintain regulatory and quality expertise in the regulatory environment and serve as a Subject Matter Expert
・Interact with internal team members, external partners and regulators to resolve regulatory matters
・Other duties

＜Requirements＞

・Ability to obtain and maintain Marketing Authorizations for Class I to III medical devices, including handling change management
・Competent in Manufacturer Registrations
・Competent in QMS audits
・Ability to work as part of a team or independently
・Able to multi-task, organize and prioritize
・Ability to appropriately interpret existing and emerging regulations, standards or guidance documents including potential impact on regulatory and quality functions
・Strong technical writing skills
・Analytical and detail oriented
・Effective leadership, mentoring and guidance skills
・Consultative leadership style
・Assertive and not afraid to ask questions
・Friendly, good attitude, customer service oriented