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Regulatory Affairs Engineering Lead - Skin Program at Neko Health - ApplyBlast

Regulatory Affairs Engineering Lead - Skin Program

Neko Health

4 months ago

Stockholm, Sweden

Onsite

Full Time

Senior

0 applicants

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About this role

Neko is seeking a Regulatory Affairs professional to lead regulatory activities for its dermatological medical devices and software applications across the EU, UK, and US markets. The role involves establishing ownership of EU MDR technical documentation, leading FDA premarket submissions, and managing post-market surveillance through cross-functional collaboration with engineering and clinical teams.

Responsibilities

Establish ownership of EU MDR technical documentation for skin program products
Lead FDA premarket submissions and CE marking activities for medical devices
Serve as primary regulatory contact for engineering and clinical teams
Manage post-market surveillance, vigilance, and complaint handling processes
Apply regulatory requirements pragmatically during fast-paced product development

Skills

Qualifications

BSc or MSc in Law, Medicine, Pharmacy, or Engineering3+ years in Regulatory Affairs or Quality Management for Medical DevicesKnowledge of ISO 13485, ISO 14971, and IEC 60601-1 series