$ads={1}
仕事内容:
Position : Technical Specialist & Scheme Manager(Active devices)
Reports to: Technical Team Manager, Active Devices
Location: Home Based - Japan
Purpose of Position
- To manage a portfolio of Medical Device CE marking and UKCA clients.
- Plan and deliver Technical File Assessments and Unannounced Audits in support of EC Certification
- Manage client projects, acting as their primary contact and after satisfactory assessment make certification recommendations for CE certificate issue
- Act as technical support to the commercial team when required
- Provide in-house and external training in areas of expertise
Essential Responsibilities
- Deliver Medical Device CE Technical File Assessment services from home office, and on-site as a fully integrated member of the Active Devices Team
- Perform Unannounced visits to medical device manufacturers globally as a technical expert
- Support the Commercial Team as it grows the customer base worldwide
- Delivery of all services within required timescales and to a high quality
- Maintaining client satisfaction whilst continuing to meet BSI’s ethical expectations
- Performing in-house training
- Maintain and expand competence in areas of technical expertise and Medical Devices certification
Dimensions
- The jobholder will be a member of the Active Devices Team reporting to a Technical Team Manager, Active Devices and work as a colleague with other members of the Medical Devices Business Stream.
- There is interface at all levels of management in client and regulatory organisations.
- Some visits to the Japan office will be expected during training.
- Some global travel is expected to perform technical assessments, unannounced visits and to attend relevant meetings and training (estimated 6-8 weeks per year).
アピールポイント:
Knowledge
- Interpretation and applications of International and National standards for the design, manufacture and regulation of medical devices.
- Understanding of Risk Management and FMEA of Electromedical Devices
- Conceptual and analytical thinking, efficiency and results orientation
- Ability to work independently with minimal supervision; self-motivated.
- A team player good at relationship building internally and externally
- Broad technical understanding of electromedical devices. Understanding of companies operating in these spaces and current industry trends.
- Thorough knowledge of Medical Device regulation and Knowledge of QMS systems for medical devices would be advantageous.
Experience
- 6+ years of Medical Device experience in a technical capacity, preferably within product design, development and testing; manufacturing experience also advantageous.
- Prefer: Research, Design and Development and Engineering (Hands on experience including Electrical, Software, Standards, Testing and Product types) experience.
Performance Development Review (PDR)
- Specific performance objectives and measures will be set and agreed between the individual and their Line Manager each year and are reviewed
- The PDR will also be used as a basis for making development and improvement plans and reaching agreement about what should be done in the future.
求める人材:
Languages
- Native Japanese language required and proficiency in spoken and written English.
勤務地:
Smoking is strictly prohibited on the workplace
アクセス:
Home based
その他:
Remote video interview
Job Type: Full-time
Salary: 9,500,000円 - 12,000,000円 per year
$ads={2}
