When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
- POSITION SCOPE:
- This position coordinates GSP management, providing a key interface between LSG RA,business partners and QA team. This position is responsible for the tracking & trending of post market regulatory compliance for LSG MD and IVD.
- KEY RESPONSIBILITIES:
- Actions or assists with MD and IVD Chinese Labelling compliance;
- Monitors the progress of complaint handling and investigation, and working with applicable individuals and departments to ensure complaint handling time requirements are met.
- Interface with QA Specialist’s to ensure complaint handling requirements are met
- Perform activities to support customer quality requirements e.g. minimum shelf life, single batch deliveries, storage and transport conditions, packaging and labeling requirements, certification requirements, lot and batch control, CoC, CoA, Supply Maps and change notification agreements.
- BS in life sciences or a relevant discipline with at least 1 years of experience in a regulatory affairs function in a biopharmaceutical company; or equivalent
experience with the regulatory submissions process, including electronic submissions.
- ISO 13485 training certificate is preferred.
- Be familiar with the laws and regulations and accord with the qualification requirements of relevant laws and regulations.
- Demonstrated ability to coordinate and work effectively with cross-functional teams
- Strong communication skills and strong organizational and time management skills.
- Strong computer skills in the following programs: MS Word, PowerPoint, Excel and MS Project. Has the ability to learn new systems quickly.
At Thermo Fisher Scientific, each one of our 50,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com