changing lives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Identify and lead the implementation of continuous improvement (process and quality) focus on exceeding customer needs, especially simplification/improvements for post marketing activities.
- Ensure post marketing activities based on the MHLW GVP/QMS Ordinance such as leading the implementation of safety measures, e.g. provide training, recall, stop shipment, report to health authorities, labeling update, preparation and distribution of safety information to medical personnel and distributors.
- Coordinate all the preparation and hosting activities in internal/external audits relating to GVP and act as a Safety Manager at the Japan commercial office.
- Communicate with manufacturers regarding product quality/services and encourage them to enhance their quality.
- Work closely with global complaint handling team and Japan commercial team and build good relationships.
- Responsible for the effective fulfillment of objectives and deadlines assigned.
- Participate in team efforts to achieve departmental and organization goals.
Additional responsibilities
- Other duties may be assigned.
QUALIFICATIONS
- In depth knowledge of Quality System regulations - ISO 13485, MHLW QMS/GVP Ordinances and PMD Act.
- Must interact well with all levels of management, co-workers, and regulators.
- Good document practice including logical writing.
- Interpersonal communication skills and work independently as well as in close collaboration with others.
- Ability to do research and come up with creative, compliant solutions for quality challenges.
- Demonstrated leadership; proven track of managing projects/people deploying planning, executing/validating and implementing phases.
- Attention to detail and ability to solve problems and communicate issues; ability to work on multiple projects.
- Computer skills including Word and Excel.
EDUCATION and/or EXPERIENCE
- Bachelor degree is required; Engineering or Science preferred
- Minimum 5 years working experience in Post marketing safety organization is required; preferably in medical device industry
- Work experience in an American and/or European company is desired
SKILLS REQUIRED: LANGUAGE SKILLS
- Fluent English required (reading, writing, and conversation)
- Excellent written and oral communications and ability to synthesize information to present internally as well as to regulatory agencies
