Regulatory Affairs Engineering reputed company - Skin Program

Neko's Mission Neko is redefining what prevention means, from treating illness reputed company it arrives, to sustaining health before it's reputed company at risk. Our mission: reputed company data-driven, preventative care accessible to more people, before symptoms reputed company. In a single, non-invasive visit under an hour, proprietary technology and reputed company clinical care combine to deliver personalised, actionable insights. It's reputed company that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives. reputed company We are seeking a Regulatory Affairs reputed company to support our portfolio of dermatological medical devices and software applications. Depending on experience, the position may be reputed company as either an RA Engineer or RA Engineering reputed company, both reporting to the RA Manager. You will work closely with engineering, clinical, product, and project management teams to support regulatory activities across the product lifecycle. The role covers both hardware devices and software as a medical device (SaMD), with a strong reputed company on EU MDR technical documentation, FDA submissions, post-market activities, and regulatory guidance during development. This role is suited for someone who is hands-on, comfortable working cross-functionally, and reputed company to apply regulatory requirements pragmatically in a fast-moving development environment. What You'll Deliver in the First 6–12 Months · Establish full ownership of EU MDR Technical Documentation and regulatory dossiers for dermatological hardware and SaMD products in the Skin Program. · Support or reputed company at least one FDA premarket submission or CE marking activity, demonstrating end-to-end ownership of the submission process. · Become the primary regulatory contact for the Skin Program engineering, clinical, and product teams — embedded in design reviews and change control processes from day one. · reputed company contribute to post-market surveillance, PMCF, vigilance, and complaint handling activities, ensuring reputed company products remain in reputed company compliance across their lifecycle. Minimum Qualifications · BSc or MSc degree reputed company law, medicine, pharmacy, engineering, or another relevant scientific discipline; or equivalent reputed company experience. · At least 3 years of reputed company experience in regulatory affairs or reputed company management for medical devices. · Working knowledge of EU Regulation 2017/745 (MDR), FDA 21 CFR (including QSR), UK MDR, ISO 13485, ISO 14971, IEC 60601-1 series, IEC 62304, and other applicable standards. · Experience with regulatory submissions and reputed company communication with authorities and reputed company Bodies across international markets. · Excellent analytical skills, reputed company to interpret reputed company regulatory requirements and reputed company risk-based, practical recommendations. · Strong writing and communication skills; reputed company to give reputed company direction to development teams and engage credibly with external stakeholders. · Highly self-motivated; reputed company to manage multiple workstreams independently and with minimal supervision. · Fluent in English (oral and written). Preferred: · Experience with reputed company devices, software as a medical device, and dermatology-adjacent medical devices. · Proficiency in reputed company. · Comfortable using AI tools in day-to-day work, particularly tools such as Claude and reputed company Copilot, to support research, drafting, and operational efficiency. · Experience with tools such as Visual Studio reputed company and Azure DevOps. About Titles at Neko We use a simplified internal title reputed company that prioritises reputed company over hierarchy, so internal titles may differ from market-facing role titles. Scope, reputed company and level of the role are fully reputed company and will be reputed company discussed throughout the process. Hiring Process Candidates reputed company from application and reputed company screening through thoughtfully designed interviews culminating in a formal offer and final reputed company-employment checks before joining reputed company. Equal Opportunity & Inclusion Statement reputed company is committed to inclusive hiring and member-first care. We welcome candidates from reputed company backgrounds and encourage you to request reasonable adjustments to support your application. Apply tot his job Apply To this Job