Job Description

Responsibility for Regulatory registration of CooperSurgical products and related licenses for CooperSurgical Japan K.K. (here in after CSJ or Company) and maintain regulatory files and licenses.

Essential Functions & Accountabilities:

• Responsible for the interactions related to regulatory registration and licenses with the PMDA, MHLW, Notified Body, Regional Health authority and other related government functions.
• Responsible for keeping updated on all Japanese requirements and changes.
• Responsible for new product registration and development of strategies including reimbursement coverage
• Responsible for maintaining regulatory licenses and sustaining regulatory filings.
• Responsible for reviewing changes. Notify Regulatory Bodies of changes that impact clearances, licenses, etc.
• Perform labeling reviews as required.
• Researching regulatory requirements to enable future development of regulatory strategies
• Create and maintain registrations procedures/protocols.
• Create, submit and maintain regulatory registration files for all device classes and respond to questions from regulatory agencies during review/submissions including reimbursement price requests.
• Create, submit and maintain QMS certification for new products and all product categories.
• Work closely with internal and external customers to achieve success.
• Support and assist with the external audit program and participate in inspections and audits by Regulatory Bodies as required.
• Partnering with International regulatory contacts to understand requirements for product registrations for new and modified products.
• Coordinate with applicable stakeholders, to support submissions and testing requirements.
• Attend and/or lead Regulatory meetings
• Review promotional materials and advise internal customers to be compliant
• Support external distributors who hold CooperSurgical product registrations
• Perform other duties or assignments as required by management

Travel:

Oversee or domestic travel about 5% = about 3 weeks per year

Qualifications

Knowledge, Skills and Abilities:

• Presentation, facilitation skills and the ability to interact and communicate with senior management and Sales/Service/Field staff at all levels.
• Project organizational skills, communication and problem-solving skills
• Must have in-depth knowledge of all applicable Quality and Regulatory standards.
• Basic computer skills (Word， Excel， Power Point) are necessary, advanced skills are preferred.
• Native level in Japanese and fluent in English (Writing, reading, listening)
• Communication skills and cooperative personality
• Familiarity with Japanese QMS ordinance and ISO13485

Work Environment:

• Office hours are 9:00 to 18:00 including 1 hour recess (Prescribed working hour is 8 hours a day)
• Flextime is introduced (Core time is between 10:00 to 15:00)
• Overtime / weekend work can occur

Experience:

• 5+ years’ experience in a medical device industry (or CRO medical device related experience) is required.

• Experience in C1/C2 Medical Device reimbursement, preferred

Education:

• Associated Degree or bachelor’s degree in engineering or life sciences or equivalent with related work experience