Senior Specialist, International Regulatory Affairs TMTT

Regulatory Toolkit; Irvine (CA); On-site; USD 92,000 - 130,000; Full time

Job summary

Edwards Lifesciences Irvine site seeks a Regulatory Affairs professional to lead complex regulatory submissions for external affiliates and coordinate between manufacturing, development teams, and regulators. You will shape regulatory strategies, assess global requirements, and guide labeling changes to ensure timely approvals.

Requirements include a bachelor's degree with 5+ years in regulatory affairs for medical devices and strong knowledge of international submission processes.

Qualifications

• Bachelor’s degree and at least 5 years related regulatory experience.
• Experience in preparing domestic and international product submissions.
• Formal government or trade association training or coursework.
• Excellent problem-solving, organizational and analytical skills.

Responsibilities

• Create complex regulatory submissions for OUS and ensure timelines and milestones.
• Represent OUS regulatory on manufacturing and product development teams.
• Provide guidance on regulatory strategy and expediting approvals.
• Assist units with registration requirements and labeling/content changes.

Skills

Attention to detail

Regulatory experience

Project coordination

Education

Bachelor's degree

Scientific discipline 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 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

Aligning 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.