Description
RESPONSIBILITIES:Tasks and responsibilities would include:
- Lead specific risk management activities within projects, as agreed with project leaders
- Facilitate development and completion of risk assessments.
- Ensure timely completion and quality of the assigned risk management files.
- Manage the overall Risk Management Program of the packaging and device development activities for within the team.
- Ensure compliance with ISO 14971 in all development projects under responsibility of our team.
- Supervise risk management activities in all development projects under responsibility of our team.
- Harmonize the medical device risk management outputs across all development projects under responsibility of our team.
- Supervise and train junior experts and other team members on Risk Management in line with local procedures and regulatory standards.
- Conduct and provide guidance on the use of risk analysis for Use, Products, Components and Processes.
- Ensure compliance with regulatory and normative guidelines focusing on medical device risk management
- Shape and improve the current internal risk management process for medical devices Guide internal and external functions on creating, reviewing and approving medical device Risk Management Files.
- Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements.
- Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects.
REQUIRED EXPERIENCE
- 2-3 years of experience as medical device risk management team leader
- Experience in managing risk management files
- Good training and presentation skills
- Good technical knowledge of parenteral packaging and medical devices
- Awareness of Human Factors Engineering
- Development and documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
- Experience of managing external suppliers
- Excellent skills in English language