Regulatory Affairs Specialist | 薬事スペシャリスト

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Job details

Company overview

We specialize in the development and marketing of medical devices. We provide advanced medical devices used primarily in the fields of cardiovascular, urology, and gastroenterology to assist in the treatment and diagnosis of patients. With an emphasis on innovative technology and research and development, we are continuously introducing products to the market that meet the needs of the medical field. Our product lineup includes catheters, stents, and endoscopic devices that boast high quality and safety. Through collaboration with medical experts, we also aim to promote effective therapies and improve medical technology. With a mission to improve the quality of life of patients, we leverage our global network to provide superior solutions to medical institutions around the world.

Responsibilities

Main responsibilities:

• Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
• Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
• Provide management team with regular updates on product registration and new regulations from government body. 
• Provides input on regulatory- related issues associated with compliance and achieving the business plans. Prioritize and plan on product registration for his/her respective product lines. 
• Preparing, coordinating and submitting regulatory applications to the local health authority. 
• Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
• Provide the management team with regular updates on product registration.
• Ensure product registrations are reviewed and renewed as required. 
• Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education. 
• Lobby the local health authorities using constructive/scientific challenges to regulations.
• This should include guidance on alternative solutions to country regulatory needs. 
• Supports tender operations by timely supply of accurate regulatory documents. 
• Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies. 
• Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation. 
• Serves as regulatory consultant to marketing team and government regulatory agencies. 
• Complete the mandatory Quality training subject to the defined timeline.
• Ensure compliance with internal Quality system and policy.

Requirements

Minimum requreiments:

• Industry experience in any of the following:
  • Clinical development, R&D or QA experience in the healthcare industry
  • Any experience in the medical device industry
  • Regulatory positions in industries other than healthcare (e.g. consumer goods, cosmetics, etc.)
• English level: business (reading and writing) *Those applying for pharmaceutical affairs must be able to handle telephone calls and meetings in English

Preferred qualifications:

• 5+ years of pharmaceutical affairs application experience (less than manager)
• Can independently manage difficult negotiations with business divisions, PMDA, and global
• Those currently learning the English language are also considered for potential hires

Salary

7 - 10 million yen

Location

Tokyo