BRS Consultant
Linh Do
Medical Device
Job number: Job-00242344
Posted: 2024-04-15
Regulatory Affairs Specialist | 薬事スペシャリスト
Global pioneer in healthcare seeks seasoned RA specialist
7 - 10 million yen
Tokyo
Medical Device
Regulatory Affairs (RA)
Job details
- Company overview
- Our client is one of the world's largest medical device manufacturers, operating as a global enterprise with over 40,000 employees worldwide. It provides innovative, non-invasive medical devices to its clients and plays a vital role in advancing medical practices by enhancing patient health, making a significant impact on the healthcare industry.
- Responsibilities
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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
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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
- Industry experience in any of the following:
- Salary
- 7 - 10 million yen
- Location
- Tokyo