Global Medical Device Regulatory Specialist

Kelly; España; On-site; EUR 50,000 - 70,000; Full time

Job summary

Kelly is seeking an experienced Regulatory Affairs Specialist to drive global market access for its medical device portfolio. You will compile technical documentation and manage submissions under EU MDR and FDA requirements, while collaborating with R&D, Quality, and Clinical teams to ensure regulatory compliance.

You will coordinate with Notified Bodies and authorities, assess changes for regulatory impact, and review labeling, IFUs, and packaging.

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or related scientific discipline.
• 2–5+ years regulatory affairs experience within the medical device sector (Class I–III).
• Solid knowledge of EU MDR 2017/745 and/or US FDA 21 CFR 820, 510(k).
• Understanding of ISO 13485, ISO 14971, IEC 62304 (if software-related).
• Excellent technical writing, analytical problem-solving, and cross-functional communication; English fluency.

Responsibilities

• Prepare, compile, and submit Technical Documentation / Design Dossiers under EU MDR and FDA 510(k).
• Act as liaison with Notified Bodies and regulatory authorities during submissions and audits.
• Assess design, manufacturing, and labeling changes for regulatory impact and submissions.
• Review and approve product labeling, IFUs, packaging, and promotional materials for compliance.
• Support ISO 13485, ISO 14971, and IEC 62304 compliance within the quality system.
• Assist with PMS updates, PSURs, vigilance evaluations, and recall documentation.

Skills

Technical writing

Analytical thinking

Cross‑functional communication

English fluency

Education

Bachelor's degree in Life Sciences/Biomedical/Pharmacy

Job description

Kelly is seeking an experienced Regulatory Affairs Specialist to drive global market access for its medical device portfolio. You will compile technical documentation and manage submissions under EU MDR and FDA requirements, while collaborating with R&D, Quality, and Clinical teams to ensure regulatory compliance.

You will coordinate with Notified Bodies and authorities, assess changes for regulatory impact, and review labeling, IFUs, and packaging.