• Corporate Regulatory Affairs Specialist

    Edwards Lifesciences (Irvine, CA)


    _This is a "Hybrid Remote" position based in Irvine, CA and hybrid remote is the ability to work onsite 3 days per week and remote 2 days per week._

     

    Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

     

    The Corporate Regulatory Affairs Specialist position provides Regulatory support and leadership to Edwards Lifesciences’ Corporate Regulatory Affairs team and cross-functional teams. The role provides a Regulatory perspective to support Edwards’ global Regulatory Compliance. The Specialist, RA role provides opportunities for global interactions to create and support solutions to enable patients’ accessibility of life-saving products and therapies through a challenging yet fulfilling role.

    How you will make an impact** **:

    + Support the implementation of various Regulatory process improvement projects by working directly with key stakeholders in all business units as well as Edwards’ international counterparts to accelerate market access routes and ensure compliance

    + Support the Regulatory Intelligence and Standards Management programs to identify, observe and analyze Regulatory changes as early as possible that may impact Edwards’ business globally

    + Gather information to provide guidance on strategies and contingency planning with respect to worldwide Regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals

    + Assist Business Unit Regulatory Affairs & Functional teams towards implementing Regulatory changes

    + Assist on process improvement/remediation projects and responses from international affiliates

    + Support FDA device listings, establishment registrations and the State of California Manufacturing Renewal Licenses

    + Support compliance initiatives relating to Regulatory requirements

    + Provide support to supervisor as needed

    What You’ll Need (Required):

    + Bachelor’s degree and minimum of (3) three years of Regulatory Affairs experience within a highly regulated industry; OR Master’s degree with no experience (or applicable internship experience)

    **What Else We Look For (Preferred)** :

    + Degree in scientific discipline

    + Medical Device, Pharma, or Biotechnology industry experience

    + ISO 13485:2016 certification, coursework, seminars, and/or other formal government and/or trade association training is preferred

    + Good knowledge and understanding of global Regulations relevant to medical devices, medium risk (i.e. Class II) and/or high risk (i.e. Class III) devices

    + Good knowledge and understanding of global Regulatory requirements for new products or product changes

    + Good knowledge of new product development systems

    + Good written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skills

    + Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

     

    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.

     

    Edwards 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.