Specialist, Regulatory Affairs TMTT

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 72,000 - 102,000; Full time

Job summary

Join a forward-thinking company dedicated to enhancing patient outcomes through innovative medical technologies. As a Specialist in Regulatory Affairs, you will play a crucial role in guiding products through complex regulatory environments. Collaborate with diverse teams to ensure compliance and support the development of life-saving medical devices. This role offers the opportunity to make a meaningful impact while working in a dynamic and supportive environment. If you are passionate about regulatory affairs and want to contribute to improving patient lives, this position is perfect for you.

Benefits

Competitive Salaries

Performance-based Incentives

Diverse Benefits Programs

Qualifications

• 3+ years of experience in regulatory affairs.
• Knowledge of global regulations for medical devices.

Responsibilities

• Prepare documentation for global regulatory submissions.
• Monitor global regulations and assess their impact on projects.

Skills

Regulatory Requirements

Documentation Preparation

Global Regulations Knowledge

Contingency Planning

Education

Bachelor's Degree

Job description

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Specialist, Regulatory Affairs TMTT

Apply locations USA - California – Irvine time type Full time posted on Posted 6 Days Ago job requisition id Req-40070

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:

• Represent the 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
• Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)
• Provide guidance on regulatory requirements necessary for contingency planning
• Monitor proposed and current global regulations and guidance; assesses impact of such regulations and guidance on assigned project(s); proposes suggestions on utilizing regulatory updates to expedite approval process
• Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
• Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions

What you will need (Required):

• Bachelor's Degree
• A minimum of 3 years related experience
• Coursework, seminars, and/or other formal government and/or trade association training

What else we look for (Preferred):

• 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
• Solid knowledge of new product development systems

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 $72,000 to $102,000 (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.

E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

About Us

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.