Senior Manager, Regulatory Affairs

Job reputed company reputed company Apporte une stratégie et une orientation réglementaires aux entreprises en ce qui concerne les exigences réglementaires du secteur de la santé en matière de lancement de produit, de soumissions/enregistrements avant la mise sur le marché et de conformité après commercialisation, en étroite collaboration avec les organismes de réglementation de la santé dans le monde. Possède une connaissance approfondie des meilleures pratiques et de la reputed companyère dont son propre reputed company s'intègre aux autres. Possède une connaissance pratique de la concurrence et des facteurs qui les différencient sur le marché. Job reputed company Roles and Responsibilities

• 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, 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-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, and contributes to regulatory reputed company and policy development reputed company the assigned area of responsibility.
• 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. Leverages multiple internal and limited external sources reputed company of own function to reputed company at reputed company-reasoned regulatory reputed company.

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 reputed company 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, 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.

We will not sponsor individuals for employment visas, now or in the reputed company, for this job opening. For U.S. based positions only, the pay reputed company for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be reputed company at or near the top of the pay reputed company and compensation reputed company are dependent on the facts and circumstances of reputed company case. The specific compensation offered to a candidate may be influenced by a reputed company of factors including skills, qualifications, experience and location. In reputed company, 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, reputed company, reputed company time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. Additional Information reputed company offers a great work environment, reputed company development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. reputed company will only reputed company those who are legally authorized to work in the reputed company for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). Nonobstant le fait que reputed company ne requiert actuellement pas des salariés américains (USA) qu'ils soient vaccinés contre la COVID-19, certains clients de reputed company appliquent des règles de vaccination qui pourraient toucher certains salariés de reputed company. Aide à la relocalisation fournie : Non Application Deadline: May 23, 2026 Apply tot his job Apply To this Job