Technical Specialist(microbiologists) 技術専門家（ 微生物医療機器）

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Job Title : Technical Specialist - Microbiology
Reports To : Technical Team Manager - Microbiology
Location : Japan(home based)

BSIはMDR、MDSAP、ISO13485、医薬品医療機器等法に基づく医療機器認証の滅菌、包装と微生物試験など微生物専門家を募集しています。このポジションは自分の専門性を生かして患者様の安全及びリスクの低減に取り組んで、製品認証を実施します。

技術専門家の責任:

•基準適合性認証における医療機器の認証審査を計画、報告および実施をします。

• 医療機器技術文書の審査 (滅菌バリデーションを含む)を実施します。

•デバイスが安全で効果的であるという客観的な証拠に基づいて、認証書の発行推薦など。

本職種は包括的な医療機器監査・認証サービスを顧客へ迅速にお届けする為、トップクラスの技術力及び知識、コミュニケーション能力、自主性をもって、ダイバーシティに富んだチームと協力して業務を遂行できる方を募集します。

資格・要求事項・求めるスキル:

•最低4年以上医療機器メーカーでの滅菌実務経験または微生物関連する実務経験（必須）

•微生物、生物、または関連する分野の学士号(またはそれ以上)　（必須）

• ISO13485、Medical Devices Directive (MDD)/EU Medical Device Regulation (MDR)などの知識と経験

• 50~60％程度の出張に対して抵抗がないこと
• ISO 13485主任審査員資格保有者優遇
• 品質管理システム実務経験（必須）
• 微生物試験と滅菌バリデーション実務経験（必須）
• 日本語：ネイティブレベル

待遇：

BSIは他社の同職の基準よりも高めの給料、グループ健康保険、在宅勤務を提供することができます。

Purpose of Position:

• Deliver audit and technical review activities in the area of sterilization and microbiology, applying appropriate technical expertise to review medical devices technical documentation and quality systems. Plan, report and perform audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements.
• Deliver microbiology technical documentation reviews and audits in support of all schemes including EU / UKCA marking, ISO 13485 and MDSAP schemes
• Provide microbiological and medical device QMS assessment expertise leadership and mentoring in areas of competence to personnel in BSI Regulatory Services Business Stream
• Provide appropriate “Technical Sales/Networking” support to the commercial team

Key Responsibilities & Accountabilities:

• Review the sterility assurance aspects of medical devices technical documentation and quality systems; deliver audits as technical expert.
• Deliver medical device CE /UKCA Marking technical review and ISO 13485 / MDSAP QMS assessment services as a fully integrated member of the Microbiology Team.
• Plan, report and perform audits of clients’ management systems to ensure compliance with regulatory and voluntary requirements.
• Manage own travel arrangements and bookings using the approved agency and expense framework.
• Review critical data (such as sterilization validation), routinely at the cutting edge of technology where no product standards or device experience exists, identify when additional external expertise is required, make safe recommendations for the issuing of BSI certificates.
• Competent to analyse risks against benefits, in an environment where a favourable decision from the notified body will potentially lead to very large commercial benefits for the device manufacturer. Must also be capable and competent to make recommendation to withdraw a certificate and deny a device market access.
• Determine when to make a recommendation to issue a certificate, based on objective evidence that the device is safe and effective.
• Provide advice and support to product technical specialists and scheme managers on certifications in area of expertise

Key Dimensions:

• The jobholder will be a member of the Microbiology Team reporting to the Technical Team Manager and work as a colleague with other members of the Regulatory Services Business Stream.
• Effectiveness will come from application of personal authority and expertise rather than hierarchical position.
• There is interface with and a need to influence all levels of the BSI organisation and at all levels of management in client and regulatory organisations.
• The position is home based. It will involve substantial travel to BSI and third party locations around the globe for business and training meetings.

Knowledge / Skills / Abilities:

• A degree-level or equivalent Microbiologist trained and experienced in the routine control and validation of sterilization and microbiological testing with a minimum of 4 years’ experience in the medical device or related regulatory field.
• Hands-on experience of working as a microbiologist in the manufacture of sterile products
• Thorough knowledge of Medical Device regulation
• Concepts and intent of product certification and service delivery
• Knowledge of business processes and the application of quality management standards
• Conceptual and analytical thinking, efficiency and focus on results
• A team player, good at relationship building internally and externally
• Broad technical understanding of clients, medical device industry and sterile products
• Ability to travel 50-60% via car ,plane and train.
• Japanese native speaker or same leave is the MUST.

Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.