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)
We are currently seeking a Regulatory Affairs Specialist to join our Compliance team.
Responsibilities
Possesses and applies knowledge, skills/abilities, and understanding of the regulatory and legal frameworks, regulatory requirements, and processes and procedures focused in the areas of our medical and healthcare portfolio. This includes but is not limited to cloud and other connected devices and platforms. This position will work in close collaboration with partners to provide knowledge and guidance to new product development teams.
Evaluates proposed products for regulatory classification and jurisdiction.
Preferred Qualifications
Advanced Medical is an integrated healthcare services and medical products company, providing customized solutions for hospitals, health systems, pharmacies, ambulatory surgery centers, clinical laboratories as well as primary care physician offices.
At Advanced Medical we supply clinically-proven medical products and healthcare cost- effective solutions that enhance supply chain efficiency from hospital to home. Advanced Medical connects patients, providers, payers, and manufacturers for integrated care coordination and better patient management.
Advanced Medical is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/ handicap status or any other legally protected characteristic.
Job Type: Full-time
Pay: $56,852.00 - $62,558.00 per year
Benefits:
Schedule:
Work Location: In person
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