Regulatory Affairs Manager – Digital Products
Location
United States
Posted
42 days ago
Salary
$132K - $198K / year
Seniority
Lead
Job Description
Job Requirements
- Bachelor’s Degree in Scientific, Engineering, Computer Science, or related 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.
- 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 within 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 make sound business and regulatory judgments independently, while recognizing when to seek guidance and support.
Benefits
- medical
- dental
- vision
- paid time off
- a 401(k) plan with employee and company contribution opportunities
- life
- disability
- accident insurance
- tuition reimbursement
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