Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Has in-depth knowledge of best practices and how own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market

Job Description

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.

Additional Information

reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

While reputed company does not currently require U.S. employees to be vaccinated against COVID-19, some reputed company customers have vaccination mandates that may apply to certain reputed company employees.

Relocation Assistance Provided: No

Application Deadline: reputed company 30, 2026 Apply To This Job