Regulatory Affairs Specialist II

Role: Regulatory Affairs Specialist II supporting product submissions, approvals, and lifecycle management for biopharma products. Objectives include preparing regulatory documentation, managing submissions such as 510(k)s, EU MDR reports, and change notifications, and ensuring compliance with global regulatory standards. Responsibilities encompass responding to agency queries, supporting post-approval activities, reviewing labeling and engineering changes, and collaborating with cross-functional teams and commercial partners. Qualifications: Bachelor's in Life Sciences or related field, 2+ years in regulatory affairs with experience in 510(k)s and EU MDR processes, knowledge of FDA and international regulatory guidelines, strong organizational, project management, and communication skills. Preferred: experience with regulatory submissions in fast-paced environments, ability to work independently and collaboratively. High-Value: focus on medical device or combination products, regulatory submissions to FDA and Notified Bodies, post-market lifecycle activities, global regulatory knowledge. Work setup: hybrid position based in Bedford, MA; travel not specified.