Senior Specialist, International Regulatory Affairs TMTT

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards Lifesciences Gruppe in Irvine, CA is seeking a Regulatory Affairs professional to lead complex domestic and international submissions. You will collaborate with manufacturing and R&D teams to ensure regulatory compliance and timely approvals, while guiding registration strategies across multiple regions.

A strong focus on documentation and cross-functional alignment is essential. The role requires a Bachelor’s degree and at least five years in regulatory affairs for medical devices, with

Qualifications

• Bachelor's Degree & a minimum of 5 years related experience
• Experience in preparing domestic & international product submissions
• Solid knowledge and understanding of global regulations relevant to medical devices

Responsibilities

• Create complex regulatory submissions for finalization and submission by OUS EW affiliates; track timelines and milestones, develop regulatory strategy
• Represent the OUS regulatory function on manufacturing and product development teams, providing input on regulatory requirements and proposing alternatives
• Provide guidance on regulatory strategies and contingency planning related to OUS requirements, including impact of global regulations and expediting approvals
• Provide guidance and feedback to business unit regulatory teams on registration requirements for new and renewal submissions, product and process changes, and labeling content

Skills

Regulatory submissions

Global regulatory knowledge

Attention to detail

Education

Bachelor's degree

Job description

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.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 managementProvide 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 approvalsProvide 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 affiliatesWhat you will need (Required):Bachelor's Degree & a minimum of 5 years related experience OR equivalent work experience based on Edwards criteriaCoursework, seminars, and/or other formal government and/or trade association trainingExperience in preparing domestic & international product submissionsWhat else we look for (Preferred) :A Bachelor’s degree in a scientific disciplineSolid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devicesSolid knowledge and understanding of global regulatory requirements for new products or product changesExperience in preparing domestic & international product submissionsSolid knowledge of new product development systemsSolid knowledge of international regulatory requirementsExcellent problem-solving, organizational, analytical and critical thinking skillsStrict attention to detailAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California, the base pay range for this position is $92,000 to $130,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.