Regulatory Affairs
Regulatory Affairs is a profession and discipline focused on ensuring that products, particularly in highly regulated industries like pharmaceuticals, medical devices, biotechnology, and food, comply with all applicable laws, regulations, and guidelines. It involves managing the entire lifecycle of a product from development through approval, marketing, and post-market surveillance. Professionals in this field act as liaisons between companies and regulatory agencies to facilitate product approvals and maintain compliance.
Developers should learn about Regulatory Affairs when working in regulated industries such as healthcare, finance, or aerospace, where software or hardware products must meet strict safety, efficacy, and quality standards. It is crucial for ensuring legal compliance, avoiding costly delays or penalties, and facilitating market access for products. For example, in medical device development, understanding regulatory pathways like FDA 510(k) or CE marking can streamline the approval process and reduce risks.