Regulatory Specialist II

Job Title: Regulatory Specialist II Location: 65 Gannett Drive, South Portland, ME 04106 Duration: 9 Months Work Arrangement: 100% Onsite Pay Range: $38 - $42 per hour (W2) We are seeking a "Regulatory Specialist II" to join one of our leading healthcare clients. Position Overview The Regulatory Affairs Specialist II role is responsible for preparing and maintaining EU Technical Files and supporting international product registrations for in vitro diagnostic (IVD) medical devices. The specialist will provide regulatory guidance throughout the product lifecycle to ensure compliance with applicable EU and international regulations. Key Responsibilities Prepare and author EU Technical Files in accordance with In Vitro Diagnostic Regulation (IVDR) requirements. Provide regulatory support for diagnostic product development and commercially released diagnostic products. Develop regulatory strategies for products in development and for product modifications to achieve EU and international clearances and approvals. Support regional regulatory teams with submissions, license renewals, and license amendments. Research, interpret, and communicate scientific and regulatory requirements to develop submission documentation. Compile, review, and publish materials required for submissions, renewals, and annual registrations. Maintain marketing authorizations, approvals, licenses, and related regulatory documentation. Assess product, manufacturing, and labeling changes to determine regulatory reporting requirements and compliance impact. Develop and maintain internal regulatory procedures and tools. Conduct informational sessions and training for internal stakeholders. Organize and maintain both hard copy and electronic regulatory files. Support and promote compliance with the company's Quality Management System in alignment with ISO, FDA, and other applicable regulatory standards. Demonstrate professional conduct with internal and external business partners in accordance with company policies and practices. Basic Qualifications Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field, or an equivalent combination of education and experience. Minimum of 4 years of experience in a Regulatory Affairs role. Strong knowledge of IVDR and EU regulatory requirements. Preferred Qualifications At least 1 year of experience in an IVD or medical device manufacturing environment. Core Competencies Solid understanding of EU and international regulatory frameworks. Strong written and verbal communication skills. Excellent time management skills with the ability to manage multiple projects simultaneously. Ability to work independently and collaboratively within a team environment. Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Visio. We are looking for the candidate who are eligible to work with any employers without sponsorship . If you're interested, please click "Apply" button.

Created: 2026-03-10