Trade Compliance Manager responsible for import/export compliance in the APAC region at Brooks. Collaborating with stakeholders to ensure adherence to trade compliance regulations.
About the role
- Sr. Regulatory Affairs Specialist supporting regulatory activities for Cochlear's implantable hearing technologies in Japan. Collaborating across functions to drive efficient product registrations and compliance.
Responsibilities
- Establish and maintain an effective NCC project management system to share regulatory affairs project information and accelerate product approval processes.
- Seek the most reasonable approach to prepare submission dossiers and respond to PMDA inquiries while maintaining high compliance levels, including conducting risk analysis when required data is insufficient.
- Prepare submission dossiers according to the latest PMDA requirements, analyze and share potential submission delays and associated risks with the team.
- Maintain comprehensive records of internal and external discussions with proper filing according to NCC RQR rules, ensuring accuracy as a key success factor.
- Demonstrate passion for technology and medical theory knowledge, and propose regulatory strategies to the team based on compliance requirements and flexibility within legal frameworks.
- Show flexibility and motivation to learn additional areas such as deeper reimbursement work or clinical matters as directed by NCC RQR Director for personal development goals.
- Possess sufficient QMS knowledge for regulatory affairs product submission work, QMS inspections, and reliability inspection work while supporting qualified supervisors.
- Demonstrate motivation to deepen QMS expertise to establish and improve the Quality Management System according to set procedures.
- Support license maintenance work including Foreign Manufacturer Registration (FMR), suggest renewal plans to NCC RQR Director with QA Sr. Specialist, and collaborate on license obtain/renewal projects.
- Maintain and develop contacts with regional colleagues, business partners, industry associates, regulatory bodies, and medical societies while monitoring government legislation relating to PMDL (Pharmaceutical and Medical Device Law).
Requirements
- Bachelor’s Degree
- 5 years or more of experience in medical device regulatory affairs in Japan (product registration of class III or IV)
- Expert knowledge of Japanese Pharmaceutical and Medical Device Law and the product registration process
- Business level English of writing and reading and moderate level of speaking
- High level of Japanese usage to understand legal term and technical terms
- Smooth operation of MS Word, PowerPoint, Excel and Visio (+Photoshop, hopefully)
- Reasonable communication skill.
- Motivation to learn new things according to the situation.
- Overseas travel (0-2/year) and domestic travel (0-10/year)
Benefits
- Health insurance
- Professional development programs
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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