Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Category: Life Science
Employment Type: Contract
Reference: BH-371432
Global Regulatory Affairs Manager II - Fort Worth
9 month contract
W2 Pay Rate: $55.00 - $59.28/hr
Position Overview
This position will independently provide tactical and strategic leadership on complex EU MDR projects within the Global Regulatory Affairs organization by actively compiling and authoring EU MDR-compliant STeD files.
Main Areas of Responsibilities
Independently lead development, remediation, planning, and authoring of EU MDR STeD files for Class IIa and IIb products.
Coordinate and lead cross-functional teams aimed at remediating MDD STeD files into MDR-compliant files, including Manufacturing, R&D, Pre-Clinical Safety, and Quality.
Lead project review meetings for management's oversight on progress and risks.
Requirements
Experience in a medical devices required.
Experience in MDR STeD file authoring required.
Develop and implement regulatory strategy aligned with business strategy.
Excellent communication and project management skills.
Preferred Skills/Qualification
Strong technical writing skills.
Strong project management skills.
B.S. required in related scientific discipline with a minimum of 5 years of regulatory experience
MS degree and 3 years of regulatory experience.
PhD and 1 years of regulatory experience.
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