Job Description
Become a Senior Regulatory Affairs Specialist with Amaris Consulting, focusing on Trauma/CMF/Biomaterials. Drive regulatory strategies to ensure successful product introductions and compliance.
With more than five years of regulatory affairs experience in the medical device industry, you will be pivotal in supporting regulatory efforts for new product launches. Your role includes preparing global documentation for key markets, liaising with health authorities, and maintaining robust compliance frameworks. You will enhance collaboration within cross-functional teams to uphold high regulatory standards.
Key Responsibilities:
• Oversee regulatory compliance for product modifications
• Submit regulatory documentation for international registrations
• Communicate design changes to regional RA teams
• Maintain databases for tracking submission statuses
• Conduct internal quality audits for compliance monitoring
Requirements:
• 5+ years in medical device regulatory ...
With more than five years of regulatory affairs experience in the medical device industry, you will be pivotal in supporting regulatory efforts for new product launches. Your role includes preparing global documentation for key markets, liaising with health authorities, and maintaining robust compliance frameworks. You will enhance collaboration within cross-functional teams to uphold high regulatory standards.
Key Responsibilities:
• Oversee regulatory compliance for product modifications
• Submit regulatory documentation for international registrations
• Communicate design changes to regional RA teams
• Maintain databases for tracking submission statuses
• Conduct internal quality audits for compliance monitoring
Requirements:
• 5+ years in medical device regulatory ...