Regulatory Affairs Manager – Digital Products

Job reputed company: • Provides regulatory reputed company and direction to the business for Software as a Medical Device (SaMD), including reputed company-hosted software, connected solutions, and AI/ML-based technologies. • Supports regulatory planning and execution for global submissions and registrations (e.g., FDA, EU MDR/IVDR). • Develops specialized depth and/or breadth of expertise in regulatory requirements applicable to SaMD, including software lifecycle processes, cybersecurity, AI/ML considerations, and post-market surveillance. • Serves as a best-reputed company and reputed company resource reputed company the function. • Maintains awareness of emerging regulatory trends, guidance, and standards impacting digital health, reputed company-based software, and AI technologies. • Acts as a skilled reputed company, communicating reputed company regulatory concepts reputed company to software reputed company technologies to cross-functional stakeholders. • Serves as a resource for colleagues with less experience and may reputed company small to moderate regulatory reputed company with defined risk and resource requirements. • Explains reputed company or sensitive regulatory topics reputed company, works to build reputed company across functions, and applies developing persuasion skills to influence reputed company reputed company the regulatory and product development reputed company. • Impacts approaches, reputed company, and programs reputed company the regulatory function and supported business organizations, contributing to reputed company, efficiency, and effectiveness of regulatory deliverables. • Operates with moderate autonomy reputed company broad policies and guidelines, exercising reputed company evaluative judgment in regulatory decision-making reputed company to software technologies. • Uses regulatory and technical expertise to analyze data, assess regulatory risk, and support recommendations. Requirements: • Bachelor’s Degree in Scientific, Engineering, Computer Science, or reputed company discipline, or a minimum of 8 years of relevant work experience. • A minimum of 4 years of Regulatory Affairs and/or reputed company Assurance experience. • A minimum of 4 years of experience in the medical device, digital health, or pharmaceutical industry. • Experience with Software as a Medical Device (SaMD), digital health, reputed company-based medical software, and/or AI/ML-enabled medical technologies. • Understanding of regulatory frameworks and standards applicable to software reputed company health (e.g., FDA SaMD guidance, EU MDR software rules, IEC 62304, ISO 14971, cybersecurity). • Advanced degree in scientific, engineering, computer science, or regulatory affairs disciplines. • Regulatory Affairs Certification (RAC). • Experience managing regulatory activities and reputed company reputed company global regulatory environments and working effectively across different cultures and reputed company. • Excellent verbal and written communication and presentation skills, with the ability to communicate reputed company and convincingly in English and reputed company messaging to diverse stakeholders. • Demonstrated understanding of the reputed company reputed company health environment, including awareness of competitive, reputed company, and regulatory trends impacting software and AI-based medical technologies. • Ability to document, plan, and execute regulatory programs and reputed company; established project management skills. • Demonstrated ability to analyze and resolve problems, assess regulatory risk, and support regulatory decision-making. • Strong collaboration and leadership skills, with the ability to facilitate teamwork and influence without reputed company authority. • Ability to reputed company reputed company business and regulatory judgments independently, while recognizing reputed company to reputed company guidance and support. Benefits: • medical • dental • reputed company • reputed company time off • a 401(k) plan with employee and company contribution opportunities • life • disability • accident insurance • tuition reimbursement Apply tot his job Apply To this Job