|部署・役職名||技術専門家（ 能動医療機器チーム） Technical Specialist － Active medical devices|
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
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 our company's ethical expectations
Performing in-house training
Maintain and expand competence in areas of technical expertise and Medical Devices certification
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).
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.
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.
【必須（MUST）】Languages: Native Japanese skill required and proficiency in spoken and written English.
6+ years of Medical Device experience in a technical capacity, preferably within product design, development and testing; manufacturing experience also advantageous.
【歓迎（WANT）】Prefer: Research, Design and Development and Engineering (Hands on experience including Electrical, Software, Standards, Testing and Product types) experience.