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Sr Quality System Specialist, RecallsApply Now Job ID R-08046 Date posted 05/08/2017
Job Description Summary
The Senior Quality System Specialist, Recalls is responsible for managing and executing the functions as the recall specialist for the business. Functions include preparing the 806 Notification to the FDA, notification for other Regulatory Bodies, notifying the BD regions affected by the recall, responding to additional requests from Regulatory Bodies and BD internal request. Maintaining the recall files and records. Terminating the recalls through the Regulatory Bodies.
Duties & Responsibilities
- Designated Recall Coordinator for Infusion
- Prepare and file the 806 Notification to the FDA in accordance with 21 CFR Part 806
- Prepare and file International FSCA documentation for the execution of the affected products located outside of the US.
- Coordinate and execute required recall activities with the BD Infusion Recall Teams and the BD International QA
- Respond to FDA and global regulatory agencies requests for additional information.
- Maintain complete recall files and BD and Global BD recall tracking records
- Prepare monthly recall update reports to the FDA and other regulatory bodies
- Prepare Requests for Recall Termination from the FDA and other regulatory bodies
- Provide support for internal quality audits of recall records
- Comply with the site Quality System
- Performs other duties as assigned.
- BA/BS degree is required. Preferred areas include clinical, engineering, science, biology, chemistry, or regulatory sciences.
- A minimum of 2 to 4 years' experience with medical device recalls around the world, and working in regulatory and/or quality assurance.
- High level of knowledge of recall requirements in the US, Canada, EU and other international countries.
- High level of knowledge with the Qualtiy and Regulatory requirements associated with recalls which include Risk Management, Complaints, Investigations, CAPAs, and Qualiy Notifications.
- Demonstrated proficiency with MS Word, PowerPoint and Excel, for the development of letters, reports, graphics and spreadsheets.
- Ability to work on multiple projects with various disciplines are essential. Position requires innovative thinking, ability to solve problems and meet deadlines.
- High level of time management skills to oversee multiple recalls during a period of time.