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)
Job Overview
The Regulatory Affairs Manager provides regulatory leadership to the Company, ensuring that Sonablate Corp. continues to meet its Quality Policy and Objectives. This role involves the development and implementation of global processes across multiple locations and stakeholders from Manufacturing Operations to Clinical Operations. The Regulatory Affairs Manager is a driven and motivated individual who has strong experiences of self-motivation in complex situations. The role is cross-functional as well as fast paced and requires a strong leader willing to wear multiple hats. If you are a highly motivated individual with a passion for regulatory affairs and a desire to make a difference, we encourage you to apply.
Duties and Responsibilities
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Qualifications/Specifications
Job Type: Full-time
Pay: $110,000.00 - $120,000.00 per year
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Ability to Relocate:
Work Location: In person
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