Principal Compliance Specialist, Product Stewardship

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Role Location:

• This role is required to be onsite. Selected candidate must reside within a reasonable commuting distance to Edwards campus in Irvine, CA. We are also willing to provide relocation assistance for candidates willing to move to Southern California.

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 Principal Compliance Specialist, Product Stewardship position is a unique career opportunity that could be your next step towards an exciting future.

The Principal Compliance Specialist, Product Stewardship will ensure Edwards devices meet the material compliance requirements of global human health and environmental regulations. This role is an integral part of Edwards Product Stewardship Group, with a growing focus on sustainability and environmental initiatives. The Principal Compliance Specialist, Product Stewardship will serve as a subject matter expert across global regulation requirements, facilitate company-wide data analysis for critical program requirements, expand Edwards global regulatory intelligence for material compliance, and lead in a cross-functional role applicable to both commercial and new product development.

This will include working with key business stakeholders internally in Quality, Regulatory Affairs, Marketing, Research and Development, Manufacturing and Global Supply Chain, as well as interacting with suppliers, working with trade organizations, detailed chemical analysis, and leadership in complex projects. The role will combine intricate data analysis, scientific critical thinking, problem solving, and effective communication to continue to expand Edwards vision as a global leader in Product Stewardship.

How You Will Make An Impact

• Lead data analysis for complex variable analysis of material compliance requirements
• Lead strategic implementation of global material compliance initiatives
• Work and collaborate with internal cross-functional teams to ensure compliance objectives are met for relevant regulations and products
• Review material compliance regulations and legislative proposals to assess business impact
• Engage with trade associations on product stewardship topics
• Conduct & participate in cross-functional meetings, workshops, forums, and associated events
• Present complex scientific information to a broad audience of varying educational backgrounds
• Acquire in-depth knowledge of Edwards products in relation to product assembly, product functionality, patient contact level, and materials

What You'll Need (Required)

• Bachelor's Degree (BS or BA) in Materials Science, Chemistry, Chemical Engineering, scientific discipline, or associated field and a minimum of six (6) years industry experience in Environmental, Health, Medical Devices, or regulated environment OR
• Master's Degree (MS or MA) in Materials Science, Chemistry, Chemical Engineering, scientific discipline, or associated field and a minimum of five (5) years industry experience in Environmental, Health, Medical Devices, or regulated environment OR
• Ph.D. in Materials Science, Chemistry, Chemical Engineering, scientific discipline, or associated field and a minimum of two (2) years industry experience in Environmental, Health, Medical Devices, or regulated environment
• This role is required to be onsite. Selected candidate must reside within a reasonable commuting distance to Edwards campus in Irvine, CA.

What Else We Look For (Preferred)

• Strong background in chemical environmental regulations as well as Product Stewardship material compliance regulations and requirements
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Strong problem-solving, organizational, analytical and critical thinking skills
• Strong project management skills
• Strict attention to detail
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to manage competing priorities in a fast-paced environment
• Ability to interact professionally with all organizational levels
• Good leadership skills and ability to influence change
• Proficient in MS Office Suite

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 $121,000 - $171,000 (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.

If you have questions about this posting, please contact [email protected]