About the role
Regulatory affairs specialists are experts in the field of regulations and legislation concerning products, often within the pharmaceutical and medical technology industries. They usually have a college education in pharmacy, law, biotechnology, or similar. Their expertise is crucial to ensure that products meet all legal requirements before they reach the market.Responsibilities
Regulatory affairs officers are responsible for preparing and managing documentation for product approvals. They collaborate with authorities such as the Medical Products Agency and stay updated on changes in legislation. They play a key role in ensuring that the company's products comply with the applicable regulations.Skills and tools
Regulatory affairs officers must have a good knowledge of relevant laws and regulations as well as the ability to interpret them. They often use databases and document management software. Strong communication skills and accuracy are essential for successfully navigating the regulatory landscape.