New · posted Oct 14
Edwards Lifesciences · Medical Devices
Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs
- Irvine, CA
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs position is a unique career opportunity that could be your next step towards an exciting future.
The 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 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, as needed
- Support compliance initiatives relating to Regulatory requirements
- Provide support to supervisor as needed
What you need
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 at least (1) one year of Regulatory Affairs experience within a highly regulated industry; or equivalent work experience based on Edwards’ criteria.
What Else We Look For (Preferred)nice to have
- 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.
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.
Pay and benefits
$74,000 – $104,000 a year
Employer providedFor California (CA), the base pay range for this position is $74,000 to $104,000 (highly experienced).
Competitive salaries
Performance-based incentives
Wide variety of benefits programs
Where you'll work
Irvine, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in Irvine, CAEqual opportunity, accessibility and legal noticesEdwards Lifesciences's statements, word for word
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Associate & Specialist roles in California11 roles publishing pay
Associate & Specialist roles in the US23 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $74,000 | — | $104,000 |
| California (middle half) | $79,750 | $89,000 | $95,000 |
| All US (middle half) | $73,000 | $89,000 | $95,000 |
This role: Edwards Lifesciences's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 201 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Edwards Lifesciences's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- GMP and compliance5
- Quality systems and risk3
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Edwards Lifesciences on Regulatory Jobs
- 23
- Open roles
- 23
- Distinct roles
- 3
- Locations
By discipline
- Quality14 61%
- Regulatory8 35%
- Compliance & Safety1 4%
By level
- Senior & Principal13 57%
- Associate & Specialist6 26%
- Director2 9%
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Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs at Edwards Lifesciences
Open until filled. $74K–$104K a year, employer provided.