Neko
Medical Devices
RegulatoryAffairsEngineeringLeadSkinProgram
“Regulatory Affairs Engineering Lead - Skin Program at Neko. Skills: Regulatory Affairs, Medical Devices, EU MDR, FDA Submissions. Establish ownership of EU MDR Technical Documentation. Establish ownership of regulatory dossiers”
What You'll Achieve.
Ensure all products remain in continuous compliance across their lifecycle
Industry & Context.
Excellent analytical skills; Able to interpret complex regulatory requirements; Provide risk-based, practical recommendations
What They're Looking For.
Must Have
BSc or MSc degree within law, medicine, pharmacy, engineering, or another relevant scientific or equivalent professional experience, At least 3 years of professional experience in regulatory affairs or quality management for medical devices, Working knowledge of EU Regulation 2017/745 (MDR), Working knowledge of FDA 21 CFR (including QSR), Working knowledge of UK MDR, Working knowledge of ISO 13485, Working knowledge of ISO 14971, Working knowledge of IEC 60601-1 series, Working knowledge of IEC 62304, Experience with regulatory submissions, Direct communication with authorities, Direct communication with Notified Bodies, Excellent analytical skills, writing and communication able to give clear direction to development teams, writing and communication able to engage credibly with external stakeholders, Fluent in English (oral and written)
Nice to Have
Experience with active devices, Experience with software as a medical device, Experience with dermatology-adjacent medical devices, Proficiency in Swedish, Comfortable using AI tools, Experience with Claude, Experience with Microsoft Copilot, Experience with Visual Studio Code, Experience with Azure DevOps
What You'll Do.
Establish ownership of EU MDR Technical Documentation
Establish ownership of regulatory dossiers
Support FDA premarket submission
Lead FDA premarket submission
Support CE marking activity
Lead CE marking activity
Act as primary regulatory contact
Contribute to post-market surveillance
Contribute to vigilance
Contribute to complaint handling
How You'll Work.
Team & Collaboration
Work closely with engineering teams; Work closely with clinical teams; Work closely with product teams; Work closely with project management teams; Embedded in design reviews; Embedded in change control processes; Give clear direction to development teams; Engage credibly with external stakeholders
Communication Scope
writing and communication able to give clear direction to development teams; writing and communication able to engage credibly with external stakeholders; Fluent in English (oral and written)
Applying for this Regulatory Affairs Engineering Lead - Skin Program role?
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