Overview
Regulatory Affairs Senior Manager Jobs in Mont-Tremblant, Canada at GE HealthCare
Title: Regulatory Affairs Senior Manager
Company: GE HealthCare
Location: Mont-Tremblant, Canada
Category:
Position: Regulatory Affairs Senior Manager at GE HealthCare
Lead regulatory strategy and navigate complex healthcare regulations as a Senior Manager at GE Health Care. Focus on Software as a Medical Device and AI/ML technologies, offering global impact and direction.
In this pivotal role, you’ll provide strategic regulatory direction for product development, launch, and compliance in the medical device and digital health sectors. Collaborate with global regulatory bodies like FDA and EU MDR, ensuring compliance with evolving frameworks. Leverage your expertise in SaMD, cybersecurity, and software lifecycle to influence cross-functional teams and drive successful outcomes.
Key Responsibilities:
• Direct regulatory strategy aligning with global health regulations
• Support global submissions and registrations with regional experts
• Develop expertise in SaMD and related regulatory requirements
• Monitor emerging regulatory trends impacting digital health
• Communicate complex regulatory concepts to stakeholders
Requirements:
• Bachelor’s degree in relevant field or 8 years experience
• Minimum 4 years in Regulatory Affairs and/or Quality Assurance
• Experience in medical device or digital health industry
Utilize your regulatory expertise to impact product success at GE Health Care and ensure compliance in a rapidly evolving sector.
#J-18808-Ljbffr