Regulatory Affairs Associate - (Malden, MA)

The Regulatory Associate will work as a member of the Quality and Regulatory group to ensure timely and successful regulatory submissions for US FDA, European MDD/ MDR, and MDSAP. This position will participate heavily with the Quality team to assure compliance, effectiveness, and maintenance of the quality management system and promote knowledge of regulatory qualifications throughout the company. It will support reporting activities both within US and EU vigilance reporting. This position will serve as the RA representative on product development teams, facilitate compliance efforts across the organization. This position will be responsible for setup, management, and overall compliance of