REGULATORY AFFAIRS FOR MEDICAL DEVICES
A dynamic world full of new challenges
Eduardo Mendoza, PhD, CRP
Sr Specialist at Zimmer BioMet
Working in the Medical Devices Regulatory Affairs field, I have realized this field is very dynamic and full of new challenges.
“The medical device industry plays a key role in the healthcare ecosystem by providing innovative solutions that improve patient outcomes. Every company seeks to innovate, whether through iterative updates to existing technology or by developing new devices that could offer a more effective treatment to a particular disease or condition”(1).
The rapid international development of new medical technology introduces new risks to the patient and the end users (e.g. surgeons, nurses, lay person). Consequently, there is an international imperative to develop and improve state, federal, and international regulations to maintain the innovation and release safe and effective medical devices to global markets.
Indeed, countries are adapting their legislation in order to cover the new technologies used in the manufacturing of medical devices, as well as to cover the increase of the combination of medical devices with software, drugs and with tissues from human and animal origins.
In this context, regulatory affairs professionals must help manufacturers to ensure compliance with applicable current and new regulatory requirements at each stage of device development.
These phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance (2).
The field of regulatory affairs spans a diverse set of disciplines, including law, economics, public policy, health, and science. The scope of a regulatory professional’s work varies, which creates interesting and well-paid job opportunities.
In conclusion, the importance of the regulatory affairs professional is increasing each year around the world. Regulatory affairs professionals are becoming essential partners for the release of safe and high performance products.