Regulatory Affairs Specialist II – Structural Heart (on-site)
Core
Provide support for the regulatory department to ensure efficient and compliant business processes, focusing on product registration documentation and post-market change management.
Role type
Individual contributor Regulatory Affairs Specialist
Builds
Regulatory submissions and change control documentation for structural heart devices
Domain
Medical devices / Structural Heart
Required skills
Regulatory compliance, GMP guidelines, written communication, project management, quality system maintenance, change control, government agency correspondence
Preferred skills
Science degree (biology, chemistry, etc.), RAC certification, analytical problem-solving
Technologies
Regulatory databases, quality management systems
Responsibilities
Analyze cumulative product changes for submissions, prepare and submit registration documentation worldwide, implement and maintain quality system effectiveness, advise on basic regulatory strategies, sign off on change control within delegated parameters, release labeling and promotional materials, conduct routine negotiations with government agencies, secure product approval, support management in resolving compliance issues
Seniority
Mid-level individual contributor