Regulatory Specialist
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.
FAQs
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