Edwards Lifesciences
Principal Compliance Specialist, Product Stewardship
Edwards Lifesciences, Irvine, California, United States, 92713
Principal Compliance Specialist, Product Stewardship
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 compliancen 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
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 Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.
Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.
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** 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 compliancen 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
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 Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.
Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.
#J-18808-Ljbffr