Senior RAQA Manager

Job Details

<Job Title>

17951 Senior RAQA Manager

<Job Descriptions>

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

<Requirements>

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

 

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