
Principal Compliance Specialist, Product Stewardship
Edwards Lifesciences, Irvine, California, United States, 92713
divh2Principal Compliance Specialist, Product Stewardship/h2pInnovation 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./ppThe 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./ppThis 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./ppHow You Will Make An Impact:/pulliLead data analysis for complex variable analysis of material compliance requirements/liliLead strategic implementation of global material compliance initiatives/liliWork and collaborate with internal cross-functional teams to ensure compliance objectives are met for relevant regulations and products/liliReview material compliance regulations and legislative proposals to assess business impact/liliEngage with trade associations on product stewardship topics/liliConduct participate in cross-functional meetings, workshops, forums, and associated events/liliPresent complex scientific information to a broad audience of varying educational backgrounds/liliAcquire in-depth knowledge of Edwards products in relation to product assembly, product functionality, patient contact level, and materials/li/ulpWhat Youll Need (Required):/pulliBachelors 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/liliMasters 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/liliPh.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/liliThis role is required to be onsite. Selected candidate must reside within a reasonable commuting distance to Edwards campus in Irvine, CA./li/ulpWhat Else We Look For (Preferred):/pulliStrong background in chemical environmental regulations as well as Product Stewardship material compliance regulations and requirements/liliStrong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills/liliStrong problem-solving, organizational, analytical and critical thinking skills/liliStrong project management skills/liliStrict attention to detail/liliMust be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects/liliAbility to manage competing priorities in a fast-paced environment/liliAbility to interact professionally with all organizational levels/liliGood leadership skills and ability to influence change/liliProficient in MS Office Suite/li/ulpAligning 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)./ppEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities./ppCOVID Vaccination Requirement/ppEdwards 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./p/div