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: The position of QARA Specialist is responsible for planning, directing, and/or coordinating regulatory affairs activities of Red Star Contract Manufacturing to ensure compliance with regulations and standard operating procedures. Additionally, the position will support special projects, such as PFMEA maintenance, internal/external audits, and other items as assigned by quality management.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)
QUALIFICATION REQUIREMENTS:
MARGINAL JOB FUNCTIONS:
PHYSICAL DEMANDS: While performing the duties of this job, the employee is regularly required to sit and talk and hear. The employee is frequently required to stand, walk; and use hands to handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIORNMENT: Associate will normally work in an office environment but may also be subject to high noise levels from machines and physical hazards from moving machine parts. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
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