Senior Specialist, International Regulatory Affairs TMTT
Edwards Lifesciences · Irvine, CA
RegulatoryFull-time$92k–$130kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Senior Specialist in International Regulatory Affairs supporting the Transcatheter Mitral and Tricuspid Therapies business unit. Develop and track complex regulatory submissions for overseas markets, represent regulatory requirements to product development teams, and provide strategic guidance on global compliance pathways.
What they're looking for
- Bachelor's degree plus minimum 5 years regulatory affairs experience or equivalent
- Formal training in government and/or trade association regulatory programs
- Experience preparing domestic and international medical device submissions
- Knowledge of global medical device regulations, Class II and III devices
- Understanding of international regulatory requirements and new product development systems
- Strong problem-solving, analytical, and organizational skills with attention to detail
What you'll be doing
- Develop complex regulatory submissions for overseas affiliates with attention to proprietary information protection
- Track regulatory timelines, document milestone achievements, and align strategies with key opinion leaders in target countries
- Represent regulatory function on manufacturing and product development teams to address requirements and resolve conflicts
- Provide guidance on regulatory strategies, contingency planning, and assessment of proposed global regulation impacts
Privacy & handoff
This role links to Edwards Lifesciences's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.