Regulatory Affairs Senior Specialist

CooperVision Japan (CVJ) is the largest operating business in the APAC region, based in Tokyo and is the second largest single country businesses in worldwide. Japan RA Senior Specialist (hereinafter referred as the RA Senior Specialist) shall be responsible for contributing and leading the Regulatory Affairs (RA) for the CooperVision Japan business. This individual is expected to be a strong assistant to the RA Manager and partner to Quality Assurance (QA) team, Vigilance team in Japan RAQA department and a proactive business partner to the Japan commercial team. The RA Senior Specialist shall follow the regulatory strategy for assigned corporate projects and obtains approvals for the Japan regulatory submissions. The RA Senior Specialist shall be responsible for all non-clinical studies required to demonstrate the safety and efficacy of contact lenses, which are classified as Class III high-risk medical devices in Japan. The focus of the role will be to exercise the leadership to translate regulatory requirements and CV NPI pipeline into practical, innovative, workable, solutions-oriented plans via interacting directly with the local health authorities MHLW and PMDA, the Global RA/R&D.

1. Establishment of non-clinical study strategies with global RA and R&D by harmonized approach to reduce the study cost and study period for early regulatory approval.
2. Assessment of global standards and local requirements and evaluation of CVI non-clinical study data for preparation of regulatory submission dossier.
3. Coordinate internal and external non-clinical studies for Japanese submission in collaboration with global RA, R&D and local external lab.
4. Consultation with local health authorities prior to submission and response to post-submission inquiries to ensure early approval.
5. Share non-clinical knowledge and information with the global and regional RA team to support the development of the organization's skills. Participate in both Ophthalmic industry and Medical Device professional societies and working groups to influence the direction of both regulations and or guidance documents. The RA Senior Specialist shall engage in his/her own talent development to ensure the continued business grow.

1. Product registration / licenses

   1. Keeps abreast and ensure compliance with the regulatory requirements and international standards within the local country.
   2. Ensures product license approvals for “Own Brand”, “Original Equipment Manufacturer” brand and “Private label” brand contact lenses obtained from local health authorities.
   3. Ensures development and submission of all required product registrations, license renewal and change notification to local health authorities. d. Serves as a primary liaison with local health authorities in Japan.
   4. Collaborates with Global RA/R&D, Global New Product Introduction (NPI) and other team members to prepare/obtain technical dossiers and information in support of regulatory filings/submissions.
   5. Collaborates with Global R&D and leads non-clinical areas such as the physical/Chemical and biological safety studies mainly.
   6. Review and approval of product labelling and IFUs to ensure compliance with applicable local regulations with collaboration with Vigilance team in Japan RAQA.
   7. Supports Japan Marketing/Professional Affairs teams on the review and approval of advertisement/promotional (Ad/Promo) materials.
   8. Monitors and communicates changes on international and local regulations, guidance documents and industry standards that impact CV Japan business and Global/Regional Regulatory Affairs. Provides gap assessments and regulatory strategies and collaborates with Global RA on the necessary action plans on these changes.
   9. Inputs Japan local requirements to Global RA through the process of NPI-Regulatory Affairs Impact Documents (RAIDS) from local country perspective.
   10. Supports and learns implementation of clinical studies in compliance with GCP and related regulations as required by local health authorities.
   11. Supports the Global/regional RA teams on the projects.

   2. Others

   1. Ensures relevant RA reports are prepared on a regular basis.
   2. Ensures relevant Global RA systems are updated.
   3. Participates and involves in any other ad-hoc projects and activities.
   4. As a SME, leads, trains and develops Japan RAQA team together with RA Manager, as applicable.

Knowledge, Skills and Abilities:

• Strong knowledge of Japan and international regulatory regulations, and legal product registration processes is required.
• Ophthalmologic product knowledge acquired through experience is a plus.
• Strong computer skills, problem solving ability, analytical, communication and collaboration skills is required. Must possess the ability/experience to read, write, and communicate effectively in English and Japanese.
• Personal attributes: Proactive, Flexible, and Multi-tasking.

Experience:

• Minimum 5 years (ideally 7 years) of in-depth and hands-on experience in the medical devices industry dealing with international country registrations including Class II - Class IV devices.
• Experience working at one company for three years or more.
• Collaboration with overseas counterparts for ensuring efficiency and collaboration in RA initiatives is a plus.
• Participation or lead in project activities and achievement of results is a plus.
• Experience working in the Ophthalmologic medical devices industry is a plus.
• Experience with representative ISO standards for medical device product development is a plus.
• Clinical-related experience is a plus.