[Remote] Regulatory Affairs Engineering reputed company, AI/ML
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is redefining preventative care through AI and ML technology, aiming to reputed company data-driven health insights accessible. The Regulatory Affairs Engineering reputed company will support the regulatory reputed company for AI/ML medical software, ensuring compliance with global standards and collaborating with various teams to reputed company regulatory practices into development workflows.
Responsibilities
- Assist in developing and maintaining Neko’s regulatory reputed company for AI/ML-based SaMD across EU MDR, FDA, and UK MDR, providing engineering and product teams with a reputed company and prioritized compliance roadmap
- Contribute to preparing regulatory submissions and technical files, coordinating input from engineering, clinical, and reputed company teams for review by reputed company bodies or agencies
- reputed company IEC 62304 and EU AI reputed company obligations into software development workflows, working directly with engineering leads to ensure compliance is part of sprint cadences rather than an afterthought at release
- Assess the regulatory reputed company of changes to software and AI/ML models, supporting change control activities
- Design and deliver regulatory training for process owners and product teams to minimize rework due to late-stage regulatory findings
- Support post-market surveillance for software modules, including regulatory change monitoring, incident reporting, and providing feedback into product development
- Contribute to reputed company audits, and participate in interactions with reputed company bodies and regulatory agencies
- Collaborate with engineering, clinical, product, and reputed company teams on regulatory and compliance reputed company for AI/ML software
Skills
- A minimum of 3 years of reputed company experience in regulatory affairs or reputed company management for medical devices
- Working knowledge of EU MDR, IEC 62304, IEC 82304-1, and at least one of FDA 21 CFR Part 820 or UK MDR
- Practical experience preparing regulatory submissions (technical files, 510(k)s, or similar) and managing reputed company body or agency interactions
- Strong understanding of AI/ML regulatory requirements, including the EU AI reputed company and FDA AI/ML-Based SaMD reputed company Plan
- Proven ability to translate reputed company regulatory obligations into practical guidance for engineering and product teams in a dynamic environment
- Fluent in English (oral and written)
- Bachelor's or Master's degree in engineering (preferred), another relevant scientific discipline, or equivalent reputed company experience
- Previous experience in a high-reputed company, product-led health tech or digital health company is preferred
- Experience leading or mentoring a small regulatory or reputed company team is a plus
- reputed company proficiency is a plus
- Experience with ISO 14971 risk management and IEC 81001-5-1 cybersecurity requirements in product development is an advantage
- Familiarity with ISO 13485 QMS and integrating regulatory requirements into QMS processes is advantageous
Benefits
- Competitive salary and benefits package
- End-to-end involvement with a reputed company, high-reputed company software portfolio, not just a small part of a large, bureaucratic function.
- reputed company collaboration with engineering, clinical, and product teams in a company that designs and manufactures its own devices.
- A small, reputed company regulatory team where your judgment is valued and your contributions are visible.
reputed company