RA Specialist- Japan

BVI® is refocusing the future of vision.
As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.
We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.
Learn more at www.bvimedical.com
Purpose

• Lead and manage the development of the submission file for Japan registration.
• Obtain the approval within timeline and on budget, utilizing internal and/or external resources.
• Maintenance of approved products, including change control
  

Key Responsibilities

• Preparation of Japanese regulatory submission file (Class I or II products)
• Collection of product information/validation documents from global team
• Coordination and negotiation with NB (inquiries/responses, various inspections)
• Management of approved products
• Regulatory review of IFUs and product brochures etc.
• Product change control (decision on whether change notification is required)
• License maintenance
• Licence management for internal and foreign manufacturing sites
• Internal audits
• Internal regulatory training
  

Qualification
Education:
Minimum: B.S. degree
Preferred: B.S. degree in a scientific or biological field
Experience:
Minimum: Over 3 years' experience of Regulatory Affairs in Medical Device Class II and above
Preferred: Over 3 years' experience of Regulatory Affairs in Medical Device either Class II, III or IV or Pharmaceutical (ophthalmology)
Minimum:

• Knowledge of PMD Act and QMS Ordinance
• Logical thinking and logical writing
• Active communication skill
• Communication in English with global team
  

Preferred:

• Working experience of file submissions for ophthalmic products
• Working experience of PMDA consultation
• Work experience in quality assurance, quality related operations and regulatory compliance
• Take an action proactively
• Solid understanding of the regulations (GCP, ICH, ISO, etc.)
• Knowledge of Ophthalmology