Regulatory Affairs Specialist

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