Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Description
The Senior Regulatory Affairs Specialist will be responsible for ensuring compliance with all regulatory requirements for medical devices and pharmaceutical products.
This position requires a deep understanding of the regulatory landscape and the ability to navigate complex regulatory processes.. This individual will provide a sense of urgency to cross-functional teams assisting with global programs and ensure effective communication with business partners worldwide. This is a full-time onsite role in Harrisburg, NC until early 2024 when the position will be located in our brand new Huntersville, NC facility.
Responsibilities:
Requirements
Qualifications:
Essential Job Functions
Competencies
Physical Requirements
Performing the duties of this job regularly involves sitting, standing, walking, hearing/listening, repetitive hand movement, grasping and reaching. Vision requirements include the ability for close vision, to adjust focus, to color code.
Mental Requirements
This position requires the ability to maintain an appropriate work pace; to comprehend and follow instructions; to read, count and compute; to exercise logic and reasoning; to organize and prioritize; to problem solve; to make decisions; to analyze and interpret data; to multi-task/re-direct and experience numerous interruptions.
Other Requirements
Some travel, approximately 15%
Work Environment
The noise level in the work environment is usually quiet to moderate.
This job description is not designed to cover an exhaustive list of duties. Other duties may be assigned and activities may change at any time with or without notice.
Safeguard Medical is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to a work environment that supports, inspires, and respects all individuals and in which personnel processes are merit-based and applied without discrimination based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Safeguard Medical believes that diversity and inclusion among our teammates is critical to our success as a global company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool.
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