Senior Specialist, International Regulatory Affairs TMTT

Edwards; Irvine (CA); Sur place; USD 92 000 - 130 000; Plein temps

Résumé du poste

Edwards is seeking a Regulatory Affairs professional to guide complex domestic and international product submissions within the Transcatheter Mitral and Tricuspid Therapies portfolio. You will partner with EW affiliates and cross-functional teams to ensure timely, compliant filings and align with global regulations.

The role requires a Bachelor's degree with at least five years of related experience and a solid understanding of regulatory requirements for medical devices.

Qualifications

• 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.

Responsabilités

• 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

Formation

Bachelor's Degree

Description du poste

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).