Detachering via YER
Medical & Health
Over deze vacature
Philips is looking for a Complaint Investigator within Regulatory Affairs.
- Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally.
- Communicate with complaint submitters to gather more data on complaints as needed, to follow up on and resolve complaint.
- Evaluate incoming complaint data and determine if it is sufficient to understand the nature of the complaint. Gathers additional data as needed.
- Initiates necessary containment.
- Analyzes complaint data and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and teams on potential product manufacturing teams on potential defects, and safety evaluations.
- Completes all needed records in a timely and accurate manner.
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
We welcome you to a challenging, innovative environment with great opportunities for you to explore. YER is preferred supplier. You will be employed by YER and seconded to Philips.
Our benefits are very competitive and designed around your preferences:
- A competitive salary depending on experience
- Extensive set of tools to drive your career, such as a personal development budget, training and coaching
- Healthy work-life balance
- Quality minded, accurate.
- Ability to work under pressure, ability to prioritize.
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.
- Works on issues where analysis of situation or data requires review of relevant factors.
- Exercises judgment within defined procedures and policies to determine appropriate action.
- Serves as individual contributor, working to meet schedules and resolve problems.
Education/ Experience & Background:
- 1+ years of experience in a medical device or regulated industry.
- Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
- Fluent in English, verbal and written is a must have.