We are seeking an experienced and proactive Regulatory Affairs Specialist to join our team. In this role, you will be responsible for preparing, compiling, and submitting technical documentation to secure and maintain general market access for our medical device portfolio. You will collaborate cross-functionally with R&D;, Quality, and Clinical teams to ensure compliance with relevant medical device regulations and standards.

Key Responsibilities

- Regulatory Submissions & Technical Files: Compile, review, and maintain Technical Documentation / Design Dossiers in accordance with EU MDR (2017/745), FDA 510(k) requirements, and other international regulatory frameworks.
- Health Authority & Notified Body Liaison: Serve as a key point of contact for Notified Bodies and regulatory authorities during submissions, audits, and deficiency responses.
- Change Control & Product Lifecycle: Assess proposed design, manufacturing, and labeling changes to determine regulatory impact and submission requirements.
- Labeling & Marketing Review: Review and approve product labeling, Instructions for Use (IFUs), packaging,



and promotional materials for regulatory compliance.
- Standards & Compliance: Support compliance with quality system standards, specifically ISO 13485 and ISO 14971 (Risk Management).
- Post-Market Surveillance (PMS): Assist with PMS updates, Periodic Safety Update Reports (PSURs), vigilance evaluations, and recall/field action documentation as needed.

Key Requirements

- Education: Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related scientific discipline.
- Experience: 2–5+ years of hands‑on Regulatory Affairs experience within the medical device sector (Class I, IIa/b, or III).
- Regulatory Knowledge: Solid working knowledge of EU MDR (2017/745) and/or US FDA regulations (21 CFR 820, 510(k)).
- Standards: Practical understanding of ISO 13485, ISO 14971, and IEC 62304 (if software‑related).
- Skills: Excellent technical writing, analytical problem‑solving, and cross‑functional communication skills; fluency in English (additional languages a plus).

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📌 Regulatory affairs specialist (España)
🏢 Kelly
📍 España