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)
Summary: Provides regulatory support to internal instrument development, and the regulatory aspects of bringing instruments to market and distribution.
Essential Duties and Responsibilities:
Qualifications:
Work Hours: 1st shift, Monday through Friday, 8:00AM to 4:30PM.
To Apply: Click on the button below, or email your resume to HR@gauthierbiomedical.com.
Additional Opportunities: Check out the Careers page on our website at www.gauthierbiomedical.com. We are growing and have several opportunities for motivated, talented individuals on 1st & 2nd shift!
All employment decisions are made on the basis of qualifications, merit and business need. Gauthier Biomedical values diversity and is an Equal Opportunity Employer. We are a Drug Free Workplace, where medical devices and rewarding careers are built.
Don't miss this remarkable opportunity to join the Gauthier Biomedical Team! Apply today!