RAQAシニアマネージャー

Job Details

<求人タイトル>

17951 RAQAシニアマネージャー

<職務内容>

Regulatory Affairs:
・Develop regulatory strategies for new products or changes
・Work with health authorities to identify potential regulatory barriers
・Regulatory and Quality impact assessment for changes to existing products
・Regulatory Intelligence; Monitoring and analysis of new regulations
・Review promotional goods and advertisements
・Establish local procedures and formats for regulatory actions

Quality Assurance:
・Establish QMS procedures and formats with MHLW Ordinance
・Ensure QMS activities are implemented and maintained with MHLW Ordinance
・Prepare records for receiving inspection and product release
・Preserve all Quality records properly
・Evaluate changes of manufacturing and inspection methods and record the assessment
・Evaluate products and services and encourage improvements with manufacturing sites
・Lead product recall
・Maintain QMS certificates
・Maintain MAH, distribution, manufacturing and repair licenses
・Identify and manage projects to improve QMS (Process excellence)
・Participate in internal and external audit programs
・Coordinate preparation and hosting activities in internal or external audits relating to QMS
・Escalate nonconformities in the Japan office when appropriate
・Responsible for identifying issues that need CAPA
・Oversee the CAPA and Internal audits processes related to QMS to ensure they are working
effectively.
・Facilitate key quality metrics and develop collection, analysis, and reporting systems, which
promote timely communication and corrective action

<応募要件>

QUALIFICATIONS:
・Knowledge of SaMD regulations and PMD Act
・Knowledge of Quality System regulations – QMS MHLW Ordinances, ISO 13485
・Interact well with management, co-workers, and regulators
・Strong written, verbal and interpersonal communication skills
・Ability to research and come up with solutions for quality challenges
・Demonstrated leadership with a proven track of project management
・Attention to detail and ability to solve problems and communicate issues
・Good Documentation Practice
・Computer skills including Word and Excel

EDUCATION and/or EXPERIENCE:
・Bachelor degree is required; Engineering or Science preferred
・Minimum 12 years working experience in RA and/or QA Organization is required; preferably in medical device industry
・Minimum of 2 years experience leading teams in achieving company goals and projects
・Work experience in an American or European company is desired

SKILLS REQUIRED: LANGUAGE SKILLS:
・Fluent English required
・Excellent written and oral communications
・Ability to synthesize information to present internally as well as to regulatory agencies

<会社概要>

デジタル歯科をリードするグローバル企業として、日本の歯科医師、医療機関や大学等に製品を提供しています。テクノロジーを使用して急成長している注目の企業です!

年収:~1,900万円(経験・能力により応相談)
就業時間: 9:00~17:45

<注目ポイント>

最先端のテクノロジーを駆使した製品が魅力で、大手外資系医療機器メーカーからも多くの人材が集まる近年急成長中の企業です!マーケット自体もまだまだ拡大余地がある中、毎年ビジネスも大幅な成果を出しており将来性も抜群です。非常にグローバルな社風で、スピーディかつフレキシブル、プロアクティブな方がぴったりの企業です。日本人コンサルタントでご相談も可能ですので、是非お気軽にお問い合わせください!

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