BRS Consultant
Go Ozawa
Medical Device
Job number: Job-00248107
Posted: 2024-03-21
Regulatory Affairs Specialist
Global pioneer in healthcare industry
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
-
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.
- And ensure compliance with internal Quality system and policy.
- Requirements
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Minimum requirements:
- Have experience in any of the following
- Clinical development, R&D or QA experience in the healthcare industry
- Any job in the medical device industry
- Regulatory positions in industries other than healthcare (e.g. consumer goods, cosmetics, etc.)
- Able to proactively think, plan and negotiate without adhering to existing strategies and processes
- There is agility to start working even if all the information is not available
- Interpret change positively and move forward
- Possess a business sense that adapts to changing situations
- English skills
- Business level reading and writing skills (Must be able to handle telephone calls and meetings)
Preferred qualifications:- Pharmaceutical affairs application experience 5 years or more (less than manager)
- Can independently manage difficult negotiations with business divisions, PMDA, and global
- English skills
- For potential recruitment, those who are still studying are also welcome.
- Have experience in any of the following
- Salary
- 7 - 10 million yen
- Location
- Tokyo