Regulatory Affairs Specialist II

To support regulatory compliance for medical devices, the full-time Regulatory Affairs Specialist II will prepare submissions for clinical investigations and commercial distribution, ensuring adherence to worldwide regulations while working remotely. Key responsibilities: Support project teams by providing regulatory input and reviewing documentation for compliance Assist in preparing regulatory submissions for approvals and review product changes for regulatory compliance Coordinate responses to regulatory agency inquiries and contribute to departmental policy improvements Required qualifications: Bachelor's degree in a scientific discipline, engineering, or equivalent required; advanced degree preferred 2-3 years of regulatory affairs experience with Class II or Class III medical devices required Strong knowledge of FDA and EU regulatory requirements and submission processes Ability to work independently and collaboratively in a fast-paced environment Proficient in English; proficiency in an additional language preferred