דרושים Senior Supplier Engineer - External Products ב-Boston Scientific ב-Japan, Tokyo

Job title: Senior Specialist, Regulatory Affairs

各製品ラインの迅速かつタイムリーな承認を確保するために、すべての製品登録に関する計画を立て、登録準備および関連書類の管理を行います。

• Provides input on regulatory related issues associated with compliance and achieving the business plan.
• Prioritize and plan on product registration for his/her respective product.
• 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.
• 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.
• 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.

• コンプライアンスおよび事業計画の達成に関連する規制関連の課題について、意見を提供します。
• 担当製品の登録を優先順位付けし、計画を立てます。
• 規制当局への申請書類の準備、調整、提出を行います。
• 承認待ちの状況を常に把握し、登録がスムーズに進むように支援します。
• 製品登録の進捗状況について、経営陣に定期的に報告します。
• 規制当局との信頼関係を維持するため、定期的な会議、ディスカッション、トレーニング、教育を通じて関係構築・維持の計画を立て、実行します。
• 規制に対して建設的かつ科学的な視点から異議を唱え、代替案を提示することで、規制当局への働きかけを行います。
• 入札業務を支援するため、正確な規制情報をタイムリーに提供します。
• 医療機器業界団体と関係を築き、業界の仲間と協力して規制当局に働きかけ、現地の政策に影響を与えます。
• 文書作成において、地域のRA（Regulatory Affairs）担当者と良好な関係を築き、迅速かつ前向きなサポートを得られるようにします。
• マーケティングチームおよび政府の規制当局に対して、規制に関するコンサルタントとしての役割を果たします。
• 定められた期限内に必須の品質トレーニングを完了し、社内の品質システムおよびポリシーを遵守します。

【必須経験】

• 医療機器クラスIII以上での薬事経験　２年以上
• 英語：ビジネスレベル
• 既存の戦略やプロセスに固執することなく Proactive に自ら考え立案し交渉できる。
• 事業部、事業部、PMDA、グローバルとの難しい交渉を単独でマネージできる、グローバルとの難しい交渉を単独でマネージできる。
• すべての情報が揃わなくても動き始めるAgilityがある。
• 変化を前向きに解釈し前に進む。
• 臨機応変に変化を捉える。

【Want要件】

Boston Scienftific

Key Responsibilities

• Lead strategic planning efforts, working in partnership with the senior executive team, to develop a fully detailed APAC Business Strategy to include stated objectives and action plans, inclusive of the market mapping, identifying potential gaps and exploiting new opportunities
• Develop the APAC Strat Plan. Develop market strategies aimed at maximizing market share, promoting prolific new product launches and building brand awareness and customer loyalty as well as healthcare economics, government affairs and reimbursement
• Execute ongoing identification of new business/ distribution opportunities and markets, tracking of competitors and market shifts, review of the broad strategic direction
• Collate market research and competitive data to enable the formation of country strategic marketing plan
• Capture and structure information from the field producing updated market mapping and business sizing
• Initiate and lead the development and implementation of customer programs, networks and advisory boards
• Manage and oversee the APAC marketing plan and budget
• Develop, lead and manage the execution of new product launches
• Design & implement conferences/symposium strategies & tactics to support the country plan
• Work with sales managers to ensure country trainers, key sales reps are adequately trained. Sets up physician and staff training and education, patient education events. Monitors post training results by physician to assess cost/benefit
• Work with operations team to manage the supply chain for products – monthly forecasts, managing backorders & planning inventory transitions for new products
• Develop appropriate clinical activities plan – registries, post market studies for divisional studies
• Quantify and prioritize reimbursement opportunities. Work with countries to help execute
• Spend 50% of time in the field helping to convert accounts, executing launches, clinical activities, gathering market & competitor information
• Make regular contact/communication with Divisional marketing personnel and sales/country management to ensure alignment of plans
• Ensure alignment with other functions (Finance, Supply Chain, Health Economics, Marketing, Clinical, Regulatory, Quality)
• Ensure awareness and compliance with applicable standard operating procedures to meet, comply and champion all quality and regulatory commitments of BSC
• Participate in driving quality awareness in every employee, while guiding the local organization towards improved performance and customer oriented initiatives

Key Qualifications

• Minimum undergraduate degree from a reputable university. Candidates with MBAs will be preferred
• Prior knowledge of core products from Urology and Women’s Health is an advantage
• Familiarity with the Japan/Australia/China market and fluency in Japanese/Mandarin would have an added advantage
• Candidates with prior experience in Urology and an understanding of the industry, procedures, solutions is preferred
• Proven track record of successful execution of tasks and possess leadership potential
• Willingness and ability to travel approximately 20% to 30% of the year
• Excellent verbal and written communication skills in English are required
• Ability to work in a fast-paced, demanding environment and multi-task
• Possess strong prioritization, project management and time management skills
• Proficient in Microsoft Excel, Word, and PowerPoint
• Mature and able to articulate ideas and concepts well in front of senior management.Ability to work across different cultures
• Displays drive and ambition to be developed and grow into more senior marketing roles

Key Responsibilities

• Own all aspects of commercial and professional education initiatives for Boston Scientific Electrophysiology in APAC
• Drive education excellence and consistency at the country level
• Work closely with the regional marketing and country marketing teams to support the execution of commercial strategies and preparation for new product launches
• Work with external vendors when necessary to develop new education capabilities
• Spend up to 25% of time in the field
• Make regular contact/communication with global education partners to ensure best practices in APAC and consistent delivery of content in the region
• Implement and maintain components of a comprehensive APAC EP clinical training program
• Evaluate and develop training program options and calendar based on identified training needs
• Lead and or complete projects that support the development and enhancement of training programs that may cross multiple regions, divisions and functions
• Mobilize the training strategy by writing and / or editing engaging and tailored trainings for the APAC EP organization that are modern, accessible and effective
• Manage, maintain and enhance APAC EP internal educational resources
• Present APAC EP clinical training program updates
• Cultivate internal relationships and develop an internal network of resources to facilitate the development and implementation of the clinical training strategy
• Collaborate with BSC’s learning and development colleagues, be familiar with the Boston Scientific Learning Management Systems, and actively leverage best practices from across Boston Scientific on various learning programs, skills, and competencies
• Lead and/or support key Clinical training initiatives as needed

Key Qualifications

• Minimum undergraduate degree with at least 10 years of relevant experience in cardiac electrophysiology and education related roles
• Prior experience in 3D EAM, RF Ablation, Pulsed Field Ablation, and an understanding of the industry, procedures, and solutions in APAC
• Familiarity with the China/Japan market
• Ability to work in a fast-paced, demanding environment and multi-task

• Ability to work across different cultures
• Regional experience is a plus
• Excellent verbal and written communication skills in English are required to enable effective collaboration with individuals globally
• Japanese or Chinese speaking ability is a plus
• Proficient in Microsoft Excel, Word, and PowerPoint