Regulatory Affairs Specialist (12‑Month Contract)

Focus: 510(k) FDA Submission - Cardiology Medical Devices

Overview

We are seeking an experienced Regulatory Affairs Specialist to support the preparation, execution, and submission of a 510(k) premarket notification for an innovative cardiology medical device. This is a 12‑month contract role with responsibility for driving regulatory strategy, ensuring compliance with FDA requirements, and coordinating cross‑functional inputs to deliver a high‑quality, timely submission.

Key Responsibilities

• Lead the planning, authoring, and compilation of the 510(k) submission, including all required modules, summaries, testing documentation, and supporting evidence.
• Develop and maintain the regulatory strategy for the product, ensuring alignment with current FDA requirements for cardiology devices.
• Review technical documentation, design history files, risk management files, clinical/bench testing data, and labeling to ensure regulatory completeness and consistency.
• Provide regulatory guidance to R&D, clinical, quality, and product teams throughout the submission process.
• Interface with FDA as needed, including coordinating requests for information (RFI), additional clarification, and other regulatory communications.
• Monitor relevant regulatory changes, guidance updates, and standards impacting cardiology medical devices.
• Ensure documentation and processes comply with 21 CFR Part 807, 820, 803, and applicable ISO standards (e.g., ISO 13485, ISO 14971).
• Support internal audits, gap assessments, and readiness checks linked to the submission.
• Maintain clear records, timelines, and progress tracking for the full submission lifecycle.

Required Qualifications

• Bachelor's degree (or higher) in engineering, life sciences, regulatory affairs, or related field.
• 5+ years' experience in Regulatory Affairs within the medical device industry.
• Proven experience preparing and submitting successful 510(k) submissions, ideally for cardiology, cardiovascular, or Class II devices.
• Strong understanding of US FDA regulations, guidance documents, and submission frameworks.
• Experience working with cross‑functional R&D and quality teams in a fast‑paced environment.
• Excellent documentation, organization, and project management skills.
• Ability to interpret technical data and translate it into regulatory‑compliant language.

Preferred Qualifications

• RAC (Regulatory Affairs Certification).
• Experience with digital health, AI‑enabled, or software‑as‑a‑medical‑device (SaMD) components.
• Familiarity with IEC 62304, IEC 60601 series, and clinical evaluation requirements for cardiology devices.