Hiring for an IMMEDIATE need. To be considered, please apply and send resume directly to mshenouda@actalentservices.com.Description:The Product Steward in this role would primarily be responsible for working with cross functional groups in supporting all products within the electrophysiology (EP) business unit. A typical day would involve lots of technical writing- updating technical reports for EUMDR on their devices as well as working with suppliers and cross functional groups to understand the materials being used and if they meet current qualifications aligned in EUMRD compliance.
Other regulatory bodies would include REACH and RohsResponsibilities include:Supports the implementation of a Product Stewardship databaseEnsures part, packaging and product information is accurately tracked in databaseWorks to Corporate Regulatory/Product Stewardship team and provide updatesEnsures compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Restricted Substance Management (RSM) requirementsFacilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processesFacilitate division compliance with all RSM reporting requirementsCoordinate with R & D support and the implementation and integration of RSM evaluationsSupport all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirementsComplies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirementsMaintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendorsSupports Environmental Management System, ISO 14001 and division sustainability efforts.Additional Skills & Qualifications:Qualifications:Bachelor's degree in Chemistry/Biology/Material Science/Engineering or like degree, open to masters degreeStrong understanding of plastics/metals/material properties or characteristics2+ years of material chemistry knowledge (high risk materials such as lead, DHP, plastics, BPA, PFE)Familiarity with regulations such as REACH, RoHS, EUMDR, Prop 65,Strong writing skillsNice to have qualifications:Previous Medical device experiencePrevious Windchill experienceProduct Stewardship focuses on minimizing the usage of certain materials of concern when possible and assessing the environmental footprint of products and packaging throughout the product life cycle, including design, manufacture, consumer use, and end of product life.Must possess critical thinking, problem solving and planning skills. Must use sound judgement and ability to build and maintain relationships with individuals and in teams.
Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people.
DE&I are embedded into our culture through:* Hiring diverse talent* Maintaining an inclusive environment through persistent self-reflection* Building a culture of care, engagement, and recognition with clear outcomes* Ensuring growth opportunities for our peopleActalent is an equal opportunity employer.About ActalentActalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500.
An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.