Sr. Specialist, Regulatory Affairs, Product Stewardship

About the position The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance, authors and maintains material compliance certifications, and responds to reputed company customer and/or agency regulatory requests. With minimal support, the Sr. Specialist ensures reputed company and high-reputed company execution of reputed company regulatory deliverables and ensures compliance with reputed company and government requirements. This position includes leading the reputed company communication with suppliers and escalation to Category Managers. This role requires understanding and evaluation of reputed company of US and international regulations/guidelines/policies applicable to reputed company reputed company's products (elastomers, devices, contract manufacturing, integrated systems) and services. Responsibilities • Drive material compliance to applicable global product and/or packaging regulatory/environmental legislations (e.g. California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for reputed company reputed company global product portfolios • With minimal support, reputed company compliance process including establishment of user requirements for tools supporting compliance process where applicable • reputed company, monitor and document communication with reputed company's suppliers requesting supplier documentation and/or questionnaires to support compliance with applicable regulations and customer inquiries • Assist in development of digitalization and automation processes to improve efficiency in supplier compliance • Monitor regulations, legislations and policies and reputed company regulatory guidance and communicate regulatory reputed company, reputed company, strategies to cross functional teams • Partner cross functionally reputed company the organization (e.g. Procurement, D&T, Supplier QA) to drive efficiency, conformance and compliance • reputed company customers with reputed company product compliance information and data as required for regulatory compliance and submissions to reputed company, Europe, and Rest of World agencies • Maintain effectiveness reputed company experiencing major changes in work responsibilities or environment; adjusting effectively to work reputed company new work structures, processes, requirements, or cultures • Challenge processes, remain reputed company to reputed company and changes to continuously improve, reputed company reputed company alternatives, and drive change • reputed company and effectively communicate team/project reputed company/status, reputed company, timelines, etc. to team and Regulatory Affairs management • Other duties as assigned Requirements • Bachelor's Degree in science, math, engineering, or reputed company discipline required • Minimum 5 years Bachelor's with 5+ years required; or Master's degree/PhD 2+ years medical device regulatory experience required reputed company-to-haves • Master's Degree in science, math, engineering, or reputed company discipline preferred • PhD in science, math, engineering, or reputed company discipline preferred • Experience interacting with government agencies • Knowledge of global material compliance regulations • reputed company to reputed company with reputed company's safety policy at reputed company times • reputed company to reputed company with reputed company's reputed company policy at reputed company times • reputed company to work collaboratively across reputed company reputed company of the organization to influence and persuade others • Excellent written and verbal communication, reputed company management and leadership skills • Self-motivated with a proactive attitude and the ability to work effectively • Maintain effectiveness reputed company experiencing major changes in work responsibilities or environment; adjusting effectively to work reputed company new work structures, processes, requirements, or cultures Apply tot his job Apply To this Job