s
sundal_ali

Sundal Ali

@sundal_ali

Sundal Ali

Pakistan
Anglais
Certaines informations sont présentées en anglais.
À propos de moi
I am a Medical Device Regulatory Affairs & Compliance Expert specializing in DRAP registration and licensing, EU MDR, FDA/510(k) support, ISO 13485 QMS, technical files, design dossiers, medical device classification, risk management, SOPs, regulatory gap analysis, and compliance documentation. I help manufacturers, importers, distributors, startups, and healthcare organizations prepare accurate regulatory submissions, strengthen compliance, and develop professional technical and QMS documentation.... Plus d’infos

Compétences

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sundal_ali
Sundal Ali
hors ligne • 

Voir mes services

Rédaction technique
I will create ce mdr technical documentation and iso 13485 qms documents
De3 500 $US / projetPlus de détails

Portfolio

Expérience professionnelle

Manager Regulatory Affairs

Shukla Medical • Temps plein

Aug 2024 - Present • 2 yrs 1 mo

Managed medical device regulatory affairs and compliance activities. Supported DRAP medical device registration, product licensing, and establishment licensing. Worked on regulatory compliance according to Medical Device Rules, 2017. Prepared and reviewed technical files, design dossiers, and regulatory documentation. Supported FDA medical device regulatory requirements and 510(k) submissions. Worked with EU MDR 2017/745 and ISO 13485:2016 requirements. Liaised with regulatory authorities and supported organizational regulatory obligations. Contributed to QMS and regulatory compliance documentation. Key Achievements: Built professional expertise in medical device regulatory affairs and compliance. Developed experience in DRAP registration, licensing, and regulatory submissions. Gained expertise in ISO 13485 QMS and medical device regulatory documentation. Developed experience supporting EU MDR and FDA requirements, including FDA 510(k). Prepared and managed technical files and design dossiers. Developed strong capabilities in regulatory documentation, compliance, and technical review. Demonstrated leadership, problem-solving, collaboration, adaptability, and team-management skills.