Regulatory Affairs Manager

Job description

We Make Life More Rewarding and Dignified Location : ​Ballina​: Department : ​Regulatory Summary: The Regulatory Affairs Manager is an experienced individual contributor responsible for developing, executing, and maintaining global regulatory strategies to support the timely commercialization and continued compliance of medical device products. The role partners closely with cross‑functional stakeholders to ensure products meet applicable regulatory, quality, and safety requirements across global markets. This role serves as a subject matter expert in global regulatory requirements, including U.S., EU, and international regulations, such as EU MDR, FDA requirements. The Regulatory Affairs Manager provides regulatory guidance across the product lifecycle, and may act as or support the Person Responsible for Regulatory Compliance (PRRC) or the EU Authorized Representative (AR), where assigned/based on location. The position promotes regulatory excellence through education, collaboration, and continuous improvement. Responsibilities: Develop and implement global regulatory strategies and associated activities to support new product development, product lifecycle management, and global...