Senior Specialist, International Regulatory Affairs TMTT

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Create complex regulatory submissions (exercising judgment to protect proprietary information) for finalization and submission by OUS EW affiliates; track timelines and document milestone achievements, develop regulatory strategy, prioritize strategies/submissions with operating plans as well as ensuring alignment with KOD in countries (e.g., OUS, [the globe minus US, EU, Canada])
• Represent the OUS regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management
• Provide guidance on strategies and contingency planning with respect to OUS regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals
• Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal registrations, product and process changes, and review of labeling content? and guidance on process improvement projects, based on prior experience and responses from affiliates

What you will need (Required):

• Bachelor's Degree & a minimum of 5 years related experience OR equivalent work experience based on Edwards criteria
• Coursework, seminars, and/or other formal government and/or trade association training
• Experience in preparing domestic & international product submissions

What else we look for (Preferred):

• A Bachelor’s degree in a scientific discipline
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices
• Solid knowledge and understanding of global regulatory requirements for new products or product changes
• Experience in preparing domestic & international product submissions
• Solid knowledge of new product development systems
• Solid knowledge of international regulatory requirements
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Strict attention to detail