※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
[Salary] 10〜15 million JPY ※Experiences and skills will be considered
◆Basic Purpose of Position:
Provide quality leadership to company.
Provide quality oversight of key quality and compliance activities conducted by company.
Provide quality oversight of Japan distribution and associated third party suppliers.
Ensure our quality system and regulatory compliance requirements are understood and complied with in-country.
Ensure Japan specific regulatory and quality system requirements are incorporated into the our Global Quality Management System.
Provide leadership and support for inspection readiness program to ensure company is inspection ready.
Set strategic direction for Quality and Compliance activities for is, aligned to our global quality objectives.
Responsible for compliance to our Quality System and applicable regulations for Japan.
Serves as the Quality Leader for the Japan Market Quality Team.
Serve as a Subject Matter Expert for the department during internal and external regulatory inspections/audits.
Provide support and assistance with Government Health Authority inquiries and inspections.
Provide leadership and support for inspection readiness.
May delegate for the Director of Product Quality as required.
◆Quality and Compliance
Develop recall strategy and lead local recall team to execute Field Actions and/or recalls.
Develop Initial and Final recall notices and submit to appropriate Health Authorities on behalf of company.
Provide Quality management oversight and support for Promotional Bundling / Customization activities.
Participate in local and global project teams to represent Quality, as required.
Complete & Maintain in-country distribution licenses as applicable for local health authorities.
Ensure on-time submission of vigilance reports to local Health Authorities, as required.
Build and maintain relationships with regulatory agencies.
Maintain awareness of industry issues, trends and changes in quality regulations and policy and ensure these changes are communicated to relevant departments and incorporated into the Quality Management System as required.
Fulfils the role of local Quality Management Representative per requirements in ISO 13485.
Maintains implementation of Quality Management System in Japan and ensures Japan specific requirements are incorporated.
Leads activities to reduce the cost of poor quality and non-compliance.
Leads significant activities within the quality system such as: change control, NC, CAPA, supplier monitoring, risk management activities, involving global or highly complex interactions.
Ensures compliant execution of QMS processes.
Has authority to disposition non-conforming material.
Provides leadership, personnel development, training, coaching and mentoring for the Japan Market Quality Team.
Responsible for staffing, salary management, and maintaining personnel files for direct reports.
Manage and provide input into department budget.
Approve controlled documents and quality records related to Japan.
Provide Quality and Regulatory guidance/training for company.
Create and approve Quality and Regulatory Compliance agreements with us and other suppliers/manufacturers as needed related to Japan.
Approve Japan Market Recall Strategies and customer communications.
Disposition of product.
Represent company at our Quality Management Review meetings and other forums where Japan Quality management is required.
3-5yrs Experience within Regulatory Environment, specifically with medical devices.
Superior spoken and written English Language skills
Advanced level of written and oral communications skills. Maturity, sound judgment and professionalism
Excellent professional & customer relations skills - ability to represent company in a professional manner.
Ability to juggle multiple projects; strong organizational skills; work independently
Ability to influence others to understand & comply with regulatory requirements.
Proficient with Microsoft Office applications
Excellent problem-solving skills, ability to think creatively within established regulatory guidelines
Superior analytical skills
Ability to interpret difficult situations and determine optimal solution to ensure customer satisfaction.
Strong policy analysis skills; ability to determine impact of regulatory changes on our business in Japan.
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.
Seniority Level: Mid-Senior level
Job Function: Health Care Provider, Quality Assurance