Apply📍 United States
🧭 Full-Time
💸 179000.0 - 272000.0 USD per year
🔍 Healthcare
🏢 Company: Cleerly👥 11-50Real Estate InvestmentPersonal FinanceBankingWealth ManagementInsurance
- Bachelor’s degree in life sciences, engineering or other relevant fields, advanced degree preferred.
- Experience: 15+ years of experience in regulatory affairs management, preferably with AI and SaMD.
- Expertise: Demonstrated knowledge of FDA regulations, ISO/EN standards and global regulatory requirements for medical devices.
- Leadership: Proven ability to lead regulatory and quality initiatives, including successful FDA submissions and audits.
- Technical Skills: Familiarity with QMS software and tools, as well as regulatory submission platforms.
- Communication: Strong communication and interpersonal skills, with the ability to engage cross-functional teams and external stakeholders.
- Problem-Solving: Skilled in identifying and addressing regulatory and quality challenges proactively.
- Experience with new product development standards and documentation for software products.
- Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
- Ability to communicate and interact with regulatory agencies and consultants.
- Excellent written and verbal skills.
- Certifications: RAC (Regulatory Affairs Certification) or similar credentials are a plus
- Product Certification: Lead efforts for regulatory submissions and approvals, including FDA traditional and special 510(k) submissions, de novo requests, CE marking, and other certifications required for market entry.
- Submission Management: Develop and implement regulatory strategy to ensure advancement of product pipeline and business continuity.
- Regulatory Planning: Develop regulatory plans for devices currently commercialized, devices undergoing FDA review per TAP and Breakthrough Device Designation programs.
- Risk Management: Develop and maintain risk management processes, ensuring compliance with ISO 14971 and related standards.
- Policy Development: Establish and maintain company policies and procedures to support regulatory and quality initiatives.
- Cross-Functional Collaboration: Work closely with R&D, product, and clinical teams to integrate regulatory requirements into product development and lifecycle management.
- Audits and Inspections: Support internal and external audits, including FDA and ISO inspections, and ensure readiness for all regulatory reviews including technical files, dossiers, Medical Device DHFs, etc.
- Training and Support: Provide training and guidance to internal teams on regulatory and quality requirements.
- Continuous Improvement: Identify opportunities to enhance regulatory and quality processes, driving efficiency and compliance.
- Regulatory Intelligence: Stay current with changes in regulations, standards, and industry trends, ensuring the company remains ahead of compliance requirements.
- Escalates business critical information in relation to regulatory impact. Evaluate risk and regulatory solutions to product and clinical safety issues during clinical phases.
- Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
- Draft Pre-Submission and regulatory application documents.Represent the company’s objectives and strategy while communicating with FDA and other regulatory bodies.
- Perform regulatory assessment of product changes, develop and implement processes to ensure regulatory compliance and risk based change assessments.
- Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
- Prepare, or contribute to the preparation of post market surveillance plans and evaluate post-market data.
Software DevelopmentProduct DevelopmentComplianceRisk Management
Posted 22 days ago
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