Johnson & Johnson Carrières
Description du poste
Requisition ID: 1905746044W
"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
ETHICON & CSS Centre of Excellence (COE) for Vigilance is a Customer Quality organization that supports numerous businesses across Johnson and Johnson companies in the field of Medical Device Vigilance. The Vigilance COE aims to deliver an efficient, effective and compliant health Authority reporting with EEA, Switzerland and Turkey in accordance with local regulations.
As part of the ETHICON and CSS Centre of Excellence for Vigilance organization the complaint analyst will focus on Vigilance reporting per Regulation (EU) 2017/745 and MED DEV 2.12-1 and management of Health Authority requests
Tasks & Responsibilities:
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
- Execute Medical Device Vigilance Decisions in accordance to MED DEV 2.12-1 and governing Medical Device Regulations for assigned business units
- Submission of Medical Device manufacturer’s incident reports in accordance to timelines outlined in MED DEV 2.12-1 and governing Medical Device Regulations for assigned business units
- Responding to Health Authority questions
- Executing Complaint Management process in accordance to established procedures
- Participate in assigned projects towards desired business outcomes.
- Promote a work environment that challenges the status quo, leads and adapts to change, as well as creates significant positive changes in the workplace.
- Create a trusting, collaborative, and ethical work environment that positively contributes to employee engagement and retention.
- Formal education in a clinical field is essential
- Fluent English (both spoken and written) is essential,
- 1-3 years’ experience working in Medical Devices field, preferable complaint management and vigilance is preferred
- Experience of GLP would be an advantage
Qualifications & Experience
- Strong decision-making skills
- Results oriented - Able to work well in a fast-paced environment
- Ability to handle multiple priorities/ sudden changes in priorities
- Strongly quality orientated
- Team player with an ability to work across functions and cultures
- Strong technical writing skills
- Good working knowledge of Excel
- IT-literate (MS Office applications, Internet browsing, e-mail)
- Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives & ISO (International Organization for Standardization) requirements
- Knowledge of human anatomy and medical terminology
- Able to work flexible hours as needed to support urgent business needs
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon SarL (8786)