Regulatory Affairs Specialist

Job Title : Regulatory Affairs Specialist Location : MA — Hybrid (3 Days Onsite) Employment Type : Contract (W2 Only) Job Summary We are seeking a Regulatory Affairs Specialist to support regulatory submissions, product documentation, and compliance activities for pharmaceutical or medical device products. Key Responsibilities Assist with preparation and maintenance of regulatory submissions Support product registrations and regulatory documentation Maintain technical files and regulatory records Assist with labeling reviews and product change assessments Support regulatory impact assessments for change controls Monitor regulatory requirements and assist with compliance activities Collaborate with Quality, Clinical, R&D, and Manufacturing teams Required Qualifications Bachelor's degree in Regulatory Affairs, Pharmacy, Life Sciences, Biomedical Engineering, or related field 0–3 years of Regulatory Affairs or regulated industry experience Basic knowledge of FDA regulatory requirements Strong writing, communication, and organizational skills Preferred Skills Familiarity with FDA submissions, eCTD, or technical documentation Knowledge of ISO 13485 or EU MDR is a plus Experience with document management systems is preferred #J-18808-Ljbffr