Welcome page Returning Candidate? Log back in! Regulatory Affairs Specialist Job Locations US-NV-Reno ID 2024-2777 Company Hamilton Company Category Hidden (28000) Position Type FullTime Company Overview Hamilton Company is a worldwide leader in the design and manufacture of manual, semi-automated and robotic products for precision fluid measuring. We specialize in the development, manufacturing and customization of precision measurement devices, automated liquid handling stations, and sample management systems. For more than 60 years, Hamilton has been satisfying customer needs by combining quality materials with skilled workmanship, ensuring the highest level of performance of every precision fluid measuring device we manufacture. Responsibilities

Responsible for analysis of new or revised regulations and standards, communication of regulatory needs to stakeholders and managing cross-functional projects to ensure compliance.

 

Create gap analyses for new or updated standards and regulations.Lead cross-functional initiatives to enable compliance to new or updated regulations and standards.Create and deploy systems to manage incoming customer regulatory requests.Create, edit and maintain technical documentation that substantiates conformance of products to regulations and standards.Create and deploy programs related to material compliance (e.g., EU REACH, EU RoHS, US EPA TSCA).

Create and deploy presentations to management and other stakeholders to convey regulatory requirements and the impact to the company.

Determine upcoming regulatory needs by monitoring regulatory climate and working with customers.  Create declarations of conformity through assessment of NRTL test reports and other technical information.Review product labeling and assist in regulatory agency audits as needed.Maintain regulatory site registrations.

Assist in management of sustainability program.

Other duties as assigned. Qualifications Expert ability to analyze regulations and standards and assess impact to quality system processes.Advanced project management skills applied to regulatory topics.Advanced technical writing skills.Excellent verbal communication skills and ability to influence and motivate peers on regulatory topics.Ability to identify and escalate compliance risks and effectively communicate to management.Familiarity with the product development lifecycle and quality management system processes.Knowledge of standards and regulations affecting laboratory equipment and in vitro diagnostics preferred.Knowledge of material compliance standards and regulations (e.g. EU RoHS, EU REACH, US EPA TSCA) preferred.Independent, self-motivated, and able to work in a team environment.Ability to manage multiple projects in a fast-paced and deadline-drive environment. Education/Experience Bachelor’s degree in a scientific or engineering discipline.At least 3 years of experience in a regulated industry analyzing standards and regulations and managing projects to enable compliance.Demonstrated experience performing regulatory gap analyses and writing technical documentation. About Hamilton Diverse portfolio of exciting and innovative design projects.Tremendous opportunities for professional growth.Commitment to sustainable design.Competitive compensation.Excellent benefit package includes medical, dental, vision insurance, paid vacation time, paid sick time, disability insurance, 401k, tuition reimbursement and much more.Solid stable company.Must pass drug and background screens.May be required to wear Personal Protective Equipment (provided by employer). Options Apply for this job onlineApplyShareEmail this job to a friendRefer Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed

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