New 
Regulatory Specialist
 Spectraforce Technologies | |
 United States, Maine, South Portland | |
 Apr 29, 2026 | |
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Position Title:Regulatory Specialist Location: South Portland ME Assignment Duration: 8 months The role will prepare documentation for EU Technical Files and international product registrations. RESPONSIBILITIES: * Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). * Provides regulatory support for diagnostic product development and commercial diagnostic products. * Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. * Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. * Researches and communicates scientific and regulatory information in order to write submission documents. * Compiles and publishes all material required for submissions, license renewals, and annual registrations. * Maintains approvals/licenses/authorizations for existing marketing authorizations. * Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. * Develops internal procedures and tools. * Conducts informational or training sessions for stakeholders. * Organizes and maintains hard copy and electronic department files. * Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies. * Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices. BASIC QUALIFICATIONS | EDUCATION: * Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience. * 4+ years' experience in Regulatory Affairs role. * Strong knowledge of IVDR and EU regulatory requirements is required. PREFERRED QUALIFICATIONS: * 1+ years' experience in an IVD or medical device manufacturing environment. COMPETENCIES: * Good knowledge of EU and international regulations. * Demonstrated written and verbal communication skills. * Strong time management skills, with the ability to work on multiple projects simultaneously. * Ability to work independently as well as within a team. * Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio | |