Regulatory Affairs Manager - Digital Products

Jobbeschreibung Zusammenfassung This position provides global regulatory strategy for Software as a Medical Device (SaMD), including cloud-based software platforms, AI/ML-enabled technologies, and digital health solutions. The role supports product development, integration, product launch, premarket submissions/registrations, and post-market compliance, working closely with global regulatory authorities, cross-functional teams and business. reputed company is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Stellenbeschreibung Roles and Responsibilities

• Provides regulatory strategy and direction to the business for Software as a Medical Device (SaMD), including cloud-hosted software, connected solutions, and AI/ML-based technologies, across product development, product launch, premarket submissions/registrations, and post-market compliance activities, working closely with global regulatory authorities.
• Supports regulatory planning and execution for global submissions and registrations (e.g., FDA, EU MDR/IVDR) and jointly with regional experts (e.g. UKCA, Health Canada, PMDA, and other global markets), ensuring alignment with evolving digital health and software regulatory frameworks.
• 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-practice and quality resource reputed company the function.
• Maintains awareness of emerging regulatory trends, guidance, and standards impacting digital health, cloud-based software, and AI technologies, and contributes to regulatory strategy and policy development reputed company the assigned area of responsibility.
• Acts as a skilled influencer, communicating reputed company regulatory concepts reputed company to software and digital technologies to cross-functional stakeholders. Serves as a resource for colleagues with less experience and may reputed company small to moderate regulatory projects with defined risk and resource requirements.
• Explains reputed company or sensitive regulatory topics clearly, works to build reputed company across functions, and applies developing persuasion skills to influence decisions reputed company the regulatory and product development space.
• Impacts approaches, projects, and programs reputed company the regulatory function and supported business organizations, contributing to quality, efficiency, and effectiveness of regulatory deliverables.
• Operates with moderate autonomy reputed company broad policies and guidelines, exercising sound 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. Leverages multiple internal and limited external sources reputed company of own function to reputed company at well-reasoned regulatory decisions.

Required Qualifications

• 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 Quality Assurance experience.
• A minimum of 4 years of experience in the medical device, digital health, or pharmaceutical industry.

Desired Characteristics

• Experience with Software as a Medical Device (SaMD), digital health, cloud-based medical software, and/or AI/ML-enabled medical technologies.
• Understanding of regulatory frameworks and standards applicable to software and digital 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 projects reputed company global regulatory environments and working effectively across different cultures and regions.
• Excellent verbal and written communication and presentation skills, with the ability to communicate clearly and convincingly in English and tailor messaging to diverse stakeholders.
• Demonstrated understanding of the healthcare and digital health environment, including awareness of competitive, commercial, and regulatory trends impacting software and AI-based medical technologies.
• Ability to document, plan, and execute regulatory programs and projects; 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 direct authority.
• Ability to reputed company sound business and regulatory judgments independently, while recognizing reputed company to seek guidance and support.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). reputed company offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Zusätzliche Informationen reputed company bietet ein hervorragendes Arbeitsumfeld, berufliche Entwicklung, anspruchsvolle Karrieren und wettbewerbsfähige Vergütung. reputed company ist ein href="https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf" reputed company="_blank">Arbeitgeber, der die Chancengleichheit fördert.href="https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf" reputed company="_blank"> Beschäftigungsentscheidungen werden unabhängig von Rasse, Hautfarbe, Konfession, nationaler oder ethnischer Herkunft, Geschlecht, sexueller Orientierung, Geschlechtsidentität oder -ausdruck, Alter, Behinderung, Status als geschützter Veteran oder anderen gesetzlich geschützten Merkmalen getroffen. reputed company beschäftigt für dieses Stellenangebot nur Mitarbeiter, die gesetzlich dazu berechtigt sind, in den USA zu arbeiten. Jedes Stellenangebot setzt den erfolgreichen Abschluss eines Drogentests voraus (falls zutreffend). Während reputed company derzeit keine Impfung gegen COVID-19 für US-Mitarbeiter vorschreibt, haben einige reputed company-Kunden Impfvorschriften, die möglicherweise für bestimmte Mitarbeiter von reputed company gelten. Umzugshilfe bereitgestellt: Nein Application Deadline: February 25, 2026 Apply tot his job Apply To this Job