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About the Role
Getinge's mission is to deliver life-saving technology to more people. To deliver value to customers and ultimately save lives, we need teamwork, forward-thinking, and game-changing colleagues. Are you looking for an inspiring career? It's here.
Responsibilities
- Comply with safety management requirements under Japanese domestic laws for medical and non-medical devices.
- Coordinate with and fulfill requirements of the global Post Marketing Surveillance system.
- Ensure compliance with local and global quality management systems and regulations.
- Perform duties under the direction and supervision of a superior within the Post Marketing Surveillance department.
- Adhere to and execute safety management requirements under the Pharmaceuticals and Medical Devices Act.
- Handle safety information and execute medical device defect reporting according to the GVP Ordinance.
- Execute and manage market corrective actions (FSCA: recalls, improvements, public awareness documents) under the direction of a superior, as per the GVP Ordinance.
- Ensure smooth operation of safety management tasks (primarily handling customer feedback related to product quality) and collaborate with relevant departments within the QMS.
- Handle complaints related to product quality.
- Report to the Pharmaceuticals and Medical Devices Agency and prefectural governments.
- Perform assigned duties under the direction and supervision of the superior (Safety Management Officer).
- Support two or more product groups as a secondary担当者 for the collection of safety information and the planning/implementation of safety measures (defect reporting, market corrective actions).
- Thoroughly understand and appropriately execute local and global safety management (Post Marketing Surveillance) operations.
- Deepen understanding of local and global QMS processes through relevant training and smoothly execute assigned tasks within those processes.
- Collaborate with global (DCU, etc.) and relevant departments to perform assigned duties.
- Thoroughly understand the business content of at least one of the following processes and perform duties under the direction and supervision of the Safety Management Officer: 1) Instructions for medical device products, 2) Leading risk management activities as a manufacturer, 3) Training for Medical Device Representatives (Sales, FSE).
- Be a strong team member within the organization.
- Perform other duties as directed by the superior.
- Correctly understand and recognize Quality Objectives and comply with quality requirements in assigned duties.
Requirements
- Bachelor's degree or equivalent experience/ability.
- Over 2 years of experience in medical device safety management.
- Expert knowledge of the Pharmaceuticals and Medical Devices Act and GVP Ordinance.
- Basic knowledge of ISO 13485:2016 and ISO 14971:2019.
- In-depth product knowledge of at least one company product group.
- Experience in good communication with global teams (DCU).
- English skills for communication with counterparts in global/regional organizations.
- Sense of responsibility for work and ability to complete tasks by deadlines, with a willingness to make every effort.
- Self-time management skills.
- Communication and cooperation skills to work individually or with teams of various functions.
- Proactive, energetic, self-managed professional with the ability to build good interpersonal relationships with other departments.
- Appropriate reporting skills and accountability for unachieved goals.
- Ability to report to superiors at the appropriate time when facing difficulties in achieving objectives and to analyze the current situation.
- High IT literacy, including proficiency in MS Office applications and global systems.
- Excellent team-building, influence, and negotiation skills within the team.
- No specific supervision/management of others.
Skills
- Safety management
- Post Marketing Surveillance
- Quality Management System (QMS)
- Product quality complaint handling
- Reporting to regulatory authorities
- Risk management
- Communication with global teams
- English proficiency
- Time management
- Teamwork
- Interpersonal skills
- IT literacy (MS Office, global systems)
- Negotiation skills
Location
- Japan
Work Type
- Full flex time
- Work from home (WFH)
- Business travel
Experience Level
- 2+ years of experience in medical device safety management
Education Level
- Bachelor's degree or equivalent experience/ability
Salary/Compensations
- Estimated annual salary: 5.5 to 7.8 million JPY (determined based on experience and skills, includes bonus)
- Monthly salary: 370,000 to 591,000 JPY (Base salary + fixed overtime allowance for 30 hours)
- Bonus: Once a year
- Salary revision: Once a year
Benefits
- Social insurance complete
- Defined contribution pension plan (corporate type DC)
- Benefit One (cafeteria plan)
- Annual holidays: 125 days or more
- Paid leave (granted according to the month of joining)
- Sick leave
- Childcare/family care leave system
- Childcare leave for nursing care
About the Company
- Getinge's mission is to deliver life-saving technology to more people.
- We provide products and solutions that improve clinical outcomes and enable optimal workflows for hospitals and life science facilities.
- Our areas include intensive care, cardiovascular surgery, operating rooms, sterile reprocessing, and life sciences.
- Getinge has over 12,000 employees worldwide, and our products and solutions are used in over 135 countries.
Equal Opportunity
- Consideration for the environment and safe business practices are reflected in decision-making.
- Use computers, telephone equipment, and other related office accessories and equipment to perform duties.
- Follow local and global Smart Workplace guidelines and ensure a proper working environment when WFH.
- Possibility of long working hours during busy periods.
- Possibility of overseas and domestic business trips, with the number of trips varying depending on project status.