Medical device regulatory workers ensure medical devices meet the necessary standards.
Medical device regulation involves ensuring that all types of medical devices meet federal regulations to meet the needs of medical facilities and patients. The U.S. Food and Drug Administration regulates companies that produce, package and sell a variety of medical devices. Many entry level professionals work in medical device regulatory positions.
Medical Device Quality Consultant
A medical device quality consultant is responsible for medical device quality assurance tasks. He must have a solid understanding of global medical device standards to ensure all devices meet the regulations. He also conducts internal and external audits of products, manufacturers and suppliers using the global standards and regulations. A medical device quality consultant provides assistance to outside audit agencies and monitors audit tasks. He also acts as a liaison with regulatory affairs departments to make sure regulatory reporting rules are followed. A medical device quality consultant must have at least a bachelor's degree and related work experience in medical device manufacturing, quality and/or product development. (As of 2010, as reported by Simply Hired, the average annual salary for medical device quality consultants is $78,000.
Regulatory Scientist
A regulatory scientist focuses on scientific research, and many concentrate on medical devices to assist in the development of more effective equipment for medical treatments. She often acts as a liaison between research and development departments to ensure quality assurance of medical devices. She assists federal agencies such as the U.S. Food and Drug Administration with the development of medical devices and approval of final products. She also helps organization quality review tasks to identify and fix problems associated with medical devices before they are available to medical facilities and consumers. Some regulatory scientists compose detailed reports on medical devices and submit them to professional medical journals. A regulatory scientist must have at least a bachelor's degree in a science related area. (As of 2010, as stated by Simply Hired, regulatory scientists earn average annual salaries of $66,000.
Regulatory Affairs Specialist
A regulatory affairs specialist organizes documents for multifaceted regulatory submissions that are necessary for global registration and licensure of medical devices. He collaborates with regulatory organizations such as the U.S. Food and Drug Administration regarding new medical devices and major modifications to existing devices. He also provides regulatory know-how and keeps up to date on global laws and regulations related to medical devices. A regulatory affairs specialist must have at least a bachelor's degree and some related experience in the medical device industry. Simply Hired states, as of 2010, regulatory affairs specialists earn average salaries of $56,000 per year.
Tags: medical devices, medical device, device quality, must have, regulatory affairs