Job Description
CooperSurgical is a leading fertility and women's healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.
CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com .
Responsibilities
Responsible for local regulatory registration and maintaining regulatory files. Work with internal and external stakeholders.
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.
- 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
Qualifications
- 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.
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 conditions:
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
