Job Title

Primary Function: Supports the execution of DHF remediation activities, ensuring compliance with EU MDR requirements, QMS templates, and traceability expectations. Key Responsibilities: · Draft, review, and update DHF documentation (e.g., product requirements, verification plans, design inputs/outputs) · Populate and validate the GSPR checklist using updated deliverables · Liaise with the onshore Regulatory Affairs Lead to ensure expectations and dependencies are met · Track and respond to regulatory queries post-delivery · Contribute to documentation planning and assumptions tracking Working Hours Requirement: ⏰ Candidate must be available to work until 12:00 PM Eastern Time (ET) to ensure communication overlap with US-based team members and stakeholders. Qualifications: · 3–5 years in Regulatory Affairs or documentation roles in the medical device industry · Familiarity with EU MDR, ISO 14971, and ISO 13485 · Experience with DHF documents, GSPR checklists, and traceability matrices · Strong written communication and document control skills