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Senior Specialist, Regulatory Affairs Surgical

Edwards Lifesciences

Irvine, CA

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JOB DETAILS
SALARY
$92,000–$130,000 Per Year
SKILLS
Analysis Skills, Biology, Cardiac Surgery, Cardiovascular, Chemistry, Clinical Assessment, Clinical Study Publications, Clinical Trial, Clinical Validation, Compensation and Benefits, Contingency Plans, Design Verification, Detail Oriented, Documentation, Engineering Drawing, Government, Government Regulations, Healthcare Providers, IDE (Integrated Development Environment), Implants, Leadership, Maintain Compliance, Manufacturing, Manufacturing Analysis, Medical Equipment, Microbiology, Patient Care, Problem Solving Skills, Product Development, Product Lifecycle, Project Development, Quality of Life, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Risk Management, Seminars, Strategic Planning, Support Documentation, Technical Delivery, Technical Writing, Technical/Engineering Design, Time Management, Vaccination, Validation Testing
LOCATION
Irvine, CA
POSTED
30+ days ago
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.


Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.


How you'll make an impact:


+ Represent Regulatory Affairs on heart valve repair product development and manufacturing teams, providing regulatory input across the full product lifecycle, including design, verification/validation, clinical evaluation, and post-market activities. Present regulatory options for meeting requirements and resolve moderately complex conflicts between regulatory expectations and development or manufacturing constraints; keep management informed of risks and alternative approaches

+ Review and approve protocols, reports, engineering drawings, procedures, labeling, and other design and manufacturing documentation to ensure compliance with applicable regulatory requirements, consistency, and technical accuracy for cardiovascular implantable devices

+ Provide regulatory guidance to support strategic and contingency planning, including development of preliminary and project-level regulatory strategies for heart valve repair technologies across U.S. and international markets

+ Prepare, compile, and support global regulatory submissions for assigned products, including: U.S. submissions (e.g., 510(k)s, IDEs, PMAs, PMA supplements, annual reports) EU submissions under the Medical Device Regulation (MDR) (e.g., Technical Documentation, Design Dossiers, STEDs, clinical evaluation documentation, and responses to Notified Body questions) Support CE marking activities and interactions with Notified Bodies for Class III implantable devices

+ Assist with GUDID/UDI submissions and maintenance of device registration and listing information

+ Track regulatory timelines, submission content, and documentation milestones to support on-time approvals and lifecycle compliance.

+ Participate in interactions with regulatory authorities and Notified Bodies, including submission review questions, deficiency responses, audits, and inspections, under the guidance of senior regulatory leadership

+ Monitor and assess global regulatory regulations, standards, and guidance relevant to heart valve repair and cardiovascular implantable devices; evaluate impact to assigned projects and propose approaches to mitigate risk or support efficient approvals

+ Review and approve labeling, product and process changes, and post-approval documentation to ensure ongoing regulatory compliance throughout the product lifecycle

+ Support post-market regulatory activities, including change assessments, vigilance inputs, and regulatory impact analyses for design or manufacturing updates


What you'll need (Required):


+ Bachelor's Degree & a minimum of 5 years related experience OR equivalent based on Edwards criteria

+ Coursework, seminars, and/or other formal government and/or trade association training


What else we look for (Preferred):


+ Bachelor’s degree in scientific discipline (e.g., Biology, Microbiology, Chemistry)

+ Experience in preparing domestic and international product submissions

+ Excellent problem-solving, organizational, analytical and critical thinking skills

+ Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

+ Full knowledge and understanding of global regulatory requirements for new products or product changes

+ Full knowledge of new product development systems

+ 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 - $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.


#LI-Onsite


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.

About the Company

E

Edwards Lifesciences