Regulatory Affairs Specialist II

Job Summary

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